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Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic
Acids and Vaccines. Lene Jorgensen (Editor),
Hanne Morck Nielson (Co-Editor). January 2010.
Advances in biotechnology have provided scientists with an increasing number
of biopharmaceuticals such as novel peptide and protein drugs as well as
nucleic acid based drugs for gene therapy. However, successful delivery of
these biopharmaceuticals is a major challenge because their molecular
properties lead to poor physical and chemical stability in the body and
limited membrane permeability. Therefore researchers are developing a range of
new delivery technologies and materials to enable these new drugs to be
delivered intact to their target sites.
Delivery Technologies for Biopharmaceuticals describes strategies to overcome the main barriers for successful delivery of therapeutic peptides, proteins, and nucleic acid-based drugs or vaccines related to the site of administration and the target site. Many of the approaches described are reported in formulations in current clinical trials as well as in marketed products. Contents include:
Delivery Technologies for Biopharmaceuticals is an essential single-volume introduction to the technologies used by researchers to ensure efficient delivery of this exciting new class of drugs. It will be of value to researchers and students working in drug delivery, formulation, biopharmaceuticals, medicinal chemistry, and new materials development. ISBN: 978-0-470-72338-8 Hardcover 442 pages. $175.00
Leung’s Encyclopedia of Common Natural Ingredients: Used in Food, Drugs
and Cosmetics, 3rd Edition. Ikhlas A. Khan,
Ehab A. Abourashed . 2009. This new Third Edition of Leung's Encyclopedia of Common Natural
Ingredients: Used in Food, Drugs, and Cosmetics arrives in the wake of
the huge wave of interest in dietary supplements and herbal medicine
resulting from both trends in health and the Dietary Supplement and
Health Education Act of 1994 (DSHEA). This fully updated and revised
text includes the most recent research findings on a wide variety of
ingredients, giving readers a single source for understanding and
working with natural ingredients. The Encyclopedia continues the successful format for entries listed
in earlier editions (consisting of source, description, chemical
composition, pharmacology, uses, commercial preparations, regulatory
status, and references). The text also features an easily accessible
alphabetical presentation of the entries according to common names, with
the index cross-referencing entries according to scientific names.
This Third Edition also features:
Ligand-Binding Assays: Development, Validation, and Implementation in the
Drug Development Arena.
Masood N. Khan (Editor),
John W. Findlay (Editor). 2009.
A consolidated and comprehensive reference on ligand-binding assays. Ligand-binding assays (LBAs) stand as the cornerstone of support for
definition of the pharmaco-kinetics and toxicokinetics of macromolecules,
an area of burgeoning interest in the pharmaceutical industry. Yet,
outside of the Crystal City Conference proceedings, little guidance has
been available for LBA validation, particularly for assays used to support
macromolecule drug development. Ligand-Binding Assays: Development,
Validation, and Implementation in the Drug Development Arena answers that
growing need, serving as a reference text discussing critical aspects of
the development, validation, and implementation of ligand-binding assays
in the drug development field.
Ligand-Binding Assays covers essential topics related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA aspects, and regulatory aspects, to software for LBAs and robotics and other emerging methodologies for LBAs. Highlights include:
Written by a team of world-recognized authorities in the field, Ligand-Binding Assays provides key information to a broad range of practitioners, both in the pharmaceutical and allied industries and in related contract research organizations and academic laboratories and, perhaps, even in the field of diagnostics and clinical chemistry. ISBN: 978-0-470-04138-3.Hardcover. 424 pages. $110.00
Dynamic Combinatorial Chemistry : In Drug Discovery, Bioorganic
Chemistry, and Materials Science.
Benjamin L. Miller (Editor). Due December 2009. Effective
techniques for applying Dynamic Combinatorial Chemistry. In a relatively
short period, Dynamic Combinatorial Chemistry (DCC) has grown from
proof-of-concept experiments in a few isolated labs to a broad
conceptual framework with applications to an exceptional range of
problems in molecular recognition, lead compound identification,
catalyst design, nanotechnology, polymer science, and others. Bringing
together a group of respected experts, this overview explains how
chemists can apply DCC and fragment-based library methods to lead
generation for drug discovery and molecular recognition in bioorganic
chemistry and materials science.
Chapters cover:
A comprehensive, single-source reference about DCC methods and applications including aspects of fragment-based drug discovery, this is a core reference that will spark the development of new solutions and strategies for chemists building structure libraries and designing compounds and materials. ISBN: 978-0-470-09603-1. Hardcover. 288 pages. $79.95.
Peptide and Protein Design for Biopharmaceutical Applications.
Knud Jensen (Editor). 2009.
Peptides serve as effective drugs in the clinic today. However the
inherent drawbacks of peptide structures can limit their efficacy as
drugs. To overcome this researchers are developing new methods to
create ‘tailor-made’ peptides and proteins with improved
pharmacological properties. Design of Peptides and Proteins provides an overview of the
experimental and computational methods for peptide and protein design,
with an emphasis on specific applications for therapeutics and
biomedical research. Topics covered include:
Design of Peptides and Proteins presents the state-of-the-art of this exciting approach for therapeutics, with contributions from international experts. It is an essential resource for academic and industrial scientists in the fields of peptide and protein drug design, biomedicine, biochemistry, biophysics, molecular modelling, synthetic organic chemistry and medicinal/pharmaceutical chemistry. ISBN: 978-0-470-31961-1. Hardcover. 306 pages. $155.00
Compatibility of Pharmaceutical Solutions and Contact Materials: Safety
Assessments of Extractables and Leachables for Pharmaceutical Products.
Dennis Jenke. 2009. Important safety aspects of compatibility
for therapeutic products and their manufacturing systems, delivery devices, and
containers. Compatibility of Pharmaceutical Products and Contact Materials
helps pharmaceutical, toxicology, analytical, and regulatory affairs
professionals assess the safety of leachable and extractable chemicals
associated with drug product packaging, manufacturing systems, and devices. The
most comprehensive resource available, its coverage includes the strategies,
tactics, and regulatory requirements for performing safety assessments, along
with the means for interpreting results. Additionally, the book's appendix
provides a database, including CAS registry numbers, chemical formulas and
molecular weights of extractable/leachable substances that have been reported in
the chemical literature. Detailing the interconnected roles played by analytical
chemistry, biological science, toxicology, and regulatory science,
Compatibility of Pharmaceutical Products and Contact Materials supplies a
much-needed, comprehensive resource to all those in pharmaceutical product or
medical device development. ISBN: 978-0-470-28176-5. 379 pp. $110.00
Pharmaceutical Data Mining: Approaches and Applications for Drug Discovery. Konstantin V. Balakin, Sean Ekins (Series Editor). due December 2009. Extracting and applying knowledge from chemical, biological, and clinical data is one of the biggest problems for the pharmaceutical industry. Focusing on diverse data mining approaches for drug discovery, including chemogenomics, toxicogenomics, and individual drug response prediction, Pharmaceutical Data Mining links theory to applications to illustrate how sophisticated computational data mining techniques can impact contemporary drug discovery and development. The book is of vital interest to pharmaceutical scientists, principal investigators and scientists, research directors, industrial and academic research libraries, and graduate students. ISBN: 978-0-470-19608-3 Hardcover 544 pages. US $125.00
The Textbook of Pharmaceutical Medicine, 6th Edition. John P. Griffin (Editor). due December 2009. The Textbook of Pharmaceutical Medicine is a standard reference for all those working in pharmaceutical medicine and the recognised text for the UK Faculty of Pharmaceutical Medicine Diploma. This is a comprehensive volume covering the processes by which medicines are developed, tested and approved. Regulations for drug development in the UK, EU, USA, Australia and Japan are discussed, providing relevant information for drug approval in the main continents where new drugs are developed. The chapters are written by leading academics, medical directors and lawyers, providing authoritative and in-depth information for trainees on the Faculty course, and for physicians working in the pharmaceutical industry. As well as thorough updating of the regulatory chapters, the 6th edition includes chapters on these vital new areas: Paediatric regulation; Ethics; Due diligence and the pharmaceutical physician. ISBN: 978-1-4051-8035-1. Hardcover. 776 pages, $259.95
Pharmaceutical Bioassays: Methods and Applications.
Shiqi Peng,
Ming Zhao. November 2009. The definitive compendium of bioassay
procedures and applications. A virtual encyclopedia of key bioassay
protocols, this up-to-date, essential resource reviews the methods and
applications of bioassays that quantify drug activity and evaluate the
validity of pharmacological models. Demonstrating the specific ways in
which various pharmaceutical bioassays interpret the activity of drug
molecules, the book covers the evaluation and screening of drug
compounds in a wide spectrum of therapeutic categories. Throughout,
the authors use various models to link experimental observations with
findings that clarify the effect of drug compounds on cellular biology
and measure the pharmacological activity of chemical substances. This
provides an important technological platform for successful drug
research and clinical therapy, making Pharmaceutical Bioassays an
ideal sourcebook for pharmacologists, pharmaceutical and medical
researchers, analytical chemists, toxicologists, and students.
Just as a fundamental knowledge of pharmaceutical bioassays is vital to understanding how bioactive agents and new drugs are defined, discovered, and developed, so too is this indispensable reference, which:
ISBN: 978-0-470-22760-2. Hardcover 480 pages. $125.00
Microarray
Innovations: Technology and Experimentation.
Gary
Hardiman. Series: Drug Discovery Series. April 2009.
Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition BABE-Solution bundle version. ZUYU Chen. March 2009.
Sample Size Calculations in Clinical Research, Second
Edition N-Solution bundle version. ZUYU Chen.
March 2009.
ISBN: 9781420082708, ISBN 10: 1420082701. Number of Pages: 304; List Price: $129.95
Safety Evaluation: International Regulations for Drug and Medical Device Approval. Shayne C. Gad & William J. Brock. due May 2009.This guide:
Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements, Second Edition. Lucia Clontz. due September 2008. provides an easy-to-follow guide to the microbial limit and bioburden testing mandated by USP-NF; Includes the most up-to-date information on biofilms and microbial control in pharmaceutical manufacturing; Reflects current industry standards, regulatory expectations, and the latest technical and scientific information; Covers biofilms, environmental monitoring, and microbial identification . Often called the "industry bible," Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements provides a practical guide to microbial limit methodologies. This new second edition has been substantially updated and expanded to include the most recent microbial limit tests and bioburden testing mandated by USP-NF. This comprehensive reference source reflects current industry standards, regulatory expectations, as well as the latest technical and scientific information. Includes New and Updated Material: Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation. Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility. ISBN: 9781420053487; ISBN 10: 1420053485. 338 pp. $189.95
Design and Analysis of Bioavailability
and Bioequivalence Studies, Third Edition.
CRC Biostatistics Series Volume: 27
Shein-Chung Chow & Jen-pei Liu. due
September 2008.
Provides detailed descriptions of
current statistical concepts,
methodologies, regulatory policies, and
public debates; Reviews the recent guidelines on
bioequivalence studies issued by the
USFDA; Includes five additional chapters in
this edition; Focuses on practical concepts rather
than technical details.
Maintaining the same practical viewpoint
as its bestselling predecessors, this
third edition presents a comprehensive,
unified summary of the vast and
continually growing literature and
research activities in the field. It
focuses on regulatory requirements,
current scientific and practical issues,
and the statistical methodology of
designing and analyzing bioequivalence
studies. The preeminent authors cover
the assessment of food effect on
bioequivalence, bioequivalence for drugs
with local action, the qualitative
determination of pharmaceutical
equivalence, bioequivalence for
biological products, medical devices,
the use of genomic information in
assessing bioequivalence, and ethnical
and gender differences in assessing
bioequivalence.
Water-Insoluble Drug Formulation, Second Edition.
Rong Liu. 2008.
Water Insolubility is the Primary Culprit in over 40% of New Drug Development Failures.
The most comprehensive resource on the topic, this second edition of Water Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe solubility properties and their impact on formulation, from theory to industrial practice. With detailed discussion on how these properties contribute to solubilization and dissolution, the text also features six brand new chapters on water-insoluble drugs, exploring regulatory aspects, pharmacokinetic behavior, early phase formulation strategies, lipid based systems for oral delivery, modified release of insoluble drugs, and scalable manufacturing aspects. The book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field. ISBN: 9780849396441; ISBN 10: 0849396441
Medical Product Regulatory Affairs: Pharmaceuticals,
Diagnostics, Medical Devices John J. Tobin,
Gary Walsh.
due September 2008.
Written in a clear and concise style by an experienced author, this
attractively-priced book covers regulatory affairs in all major global
markets for pharmaceuticals and medical devices, making it the most
comprehensive in its field.
Following a look at drug development, complete sections are devoted to
national and EU regulatory issues, manufacturing license application and
retention, and regulation in the USA. Other topics dealt with include CDER,
CBER and marketing and manufacturing licenses, the ICH process and Good
Laboratory/Clinical/Manufacturing Practices.
Everything pharmacologists, bioengineers, pharma engineers, students in
pharmacy and those working in the pharmaceutical industry need to know about
medical regulatory affairs.
ISBN: 978-3-527-31877-3.
Hardcover.
297 pages September 2008. $100.00
Validation of Cell-Based Assays in the GLP Setting: A
Practical Guide. Uma Prabhakar (Editor),
Marian Kelley (Editor). 2008. The use of
cell-based assays within pharmaceutical and biotechnology
companies is driven in large part by the need to evaluate the
plethora of drug targets derived from genomics and proteomics. In
addition, the potential of biomarkers to facilitate the
development of effective and safe drugs is being recognized as an
integral part of all phases of drug development, and cell-based
technologies are a critical part of biomarker discovery and
development. Despite this critical role, cell-based assays have
not been standardized and made compliant with Good Laboratory
Practice guidelines. In this book, the editors have collected assays for which validation
procedures have been developed, making this a vital purchase for anyone
using such assays in drug development. This book:
Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development. ISBN: 978-0-470-02876-6. Hardcover. 312 pages. $150.00
Pharmaceutical
Dosage Forms: Tablets, Third Edition Volume 1: Unit Operations and
Mechanical Properties.
Larry
L. Augsburger & Stephen W. Hoag. 2008.
Pharmaceutical Dosage Forms: Tablets, Volume 1 examines the
fundamental physical and chemical processes that the different unit oprations
use, and then applies this knowledge to the discussion of the varying unit
operations and processes.
ISBN:
9780849390142;
ISBN
10: 0849390141,
Number
of Pages: 656. List
Price: $199.95
Pharmaceutical
Dosage Forms: Tablets, Third Edition Volume 2: Rational Design and
Formulation. 2008. Pharmaceutical Dosage Forms: Tablets, Third Editionis acomprehensive
treatment of the design, formulation, manufacture, and evaluation of the
tablet dosage form. The ultimate goal of drug product development is to
design a system that maximizes the therapeutic potential of the drug
substance and facilitates its access to patients; Volume 2
focuses on the rational design, and formulation of a tablet and includes
chapters with practical illustrations and formulation examples. ISBN:
9780849390159; ISBN 10:
084939015X. Number of
Pages: 568. List
Price: $199.95
Pharmaceutical
Dosage Forms: Tablets, Third Edition Volume 3: Manufacture and Process
Control.
Larry L. Augsburger & Stephen W. Hoag. Publication Date: 6/3/2008.
This text addresses testing and evaluation of tablets, and setting up
specification for manufacture; focuses on new regulatory policies that
address international harmonization and proposes the use of modern process
analyzers or process analytical chemistry tools to achieve real-time
control and quality assurance during manufacturing. Pharmaceutical
Dosage Forms: Tablets, Third Edition is a comprehensive treatment
of the design, formulation, manufacture, and evaluation of the tablet
dosage form. Volume 3 ties the other volumes in the
Third Edition together to show how the information learned in the
previous chapters fits together to make tablet on a commercial scale.
ISBN: 9780849390166; ISBN 10: 0849390168 Number of Pages:
328. List Price: $199.95
Pharmaceutical Dosage Forms: Tablets, Third Edition (Three-Volume Set). Larry L. Augsburger & Stephen W. Hoag
List Price:
$549.95
ISBN:
9781420063455
ISBN 10:
1420063456
Pharmaceutical Project Management, Second Edition. Anthony Kennedy. Series: Drugs and the Pharmaceutical Sciences Volume: 182
List Price:
$199.95
ISBN:
9780849340246
ISBN 10:
0849340241
Publication Date:
3/17/2008
Number of Pages:
280
New updated material to include:
· expert recommendations and informative articles on decision-making
· resource allocation
· system selection
· team leadership
· skill sets strategies
· planning principles It covers primary project management objectives, functions, and descriptions of the nature and execution of work activities in a clear and reader-friendly format to illustrate key characteristics and objectives, assist managers in projecting the risks and challenges of each position, and supply concise recommendations for successful project planning. Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through manufacturing and launch.
Drug-Drug Interactions, Second Edition. A. David Rodrigues. Series: Drugs and the Pharmaceutical Sciences Volume: 179
· expands coverage of Michaelis-Menten kinetics describing enzyme-catalyzed biotransformation reactions to include non-Michaelis kinetics
· presents state-of-the-science knowledge related to the different influx (SLT) and efflux (ABC) transporters
· describes different approaches for studying the structure and function of human cytochromes P450
·
discusses in silico (computer-based) approaches used by researchers in the field
of drug interactions
Helping researchers predict drug interactions in a more accurate and effective
manner, this comprehensive volume covers every critical aspect of
metabolism-based drug-drug interactions, including preclinical, clinical,
toxicological, regulatory, and marketing perspectives by renowned thought
leaders in their respective fields. Thoroughly updated, the Second Edition
reflects key developments in the field, including an improved understanding of
the relationship between transporters and enzymes in drug metabolism and drug
interactions. Formatted to benefit the reader, this source provides helpful case
examples, representative enzyme systems, and computer-aided modeling, as well as
200 valuable tables, equations, drawings, and photographs to clarify key
concepts.
List Price:
$249.95
ISBN:
9780849375934
ISBN 10:
0849375932
Publication Date:
2/8/2008
Number of Pages:
768
Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition. Stephen P. Denyer & Rosamund Baird .2006.
In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores monitoring microbiological quality, the preservation of pharmaceutical formulations and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity testing, and the evaluation of contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. Concerns with contamination will continue to be inextricably linked to the development of pharmaceuticals and medical devices. Many new methods and regulations have been developed to meet those concerns. This book provides a comprehensive distillation of information that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development. Number of Pages: 608. ISBN: 0748406158. $159.95
Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, Sixth Edition. Series: Drugs and the Pharmaceutical Sciences Volume: 169. Joseph Nally. 2006. Building on the solid foundation of the Fifth Edition and previous editions, this Sixth Edition provides readers with fundamental knowledge of CGMP regulations and current industry applications and practices. Each chapter has been updated and this text supplies new and must-have information regarding the latest FDA guidance documents quality systems approach risk analysis and management :
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. Number of Pages: 700. ISBN: 0849339723. $249.95
Environmental Monitoring for Cleanrooms and Controlled Environments. Series: Drugs and the Pharmaceutical Sciences Volume: 164. Anne Marie Dixon. 2006. Providing must-have information on the entire subject of environmental monitoring, this text presents background information on the performance of aerosols in cleanrooms or controlled environments provides sections on particle, viable air, and surface monitoring, which include considerations for optimal equipment selection, operation, maintenance, data generation and analysis, and management discusses aseptic processing simulations in clear and concise terms to ensure acceptability of the process . A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient. Number of Pages: 256. ISBN: 0824723597. $199.95
Pharmaceutical Isothermal Calorimetry. Simon Gaisford & Michael A. A. O'Neill. 2006. Offering a problem-based approach to the material, with numerous examples, this source provides an in-depth user guide that offers step-by-step instruction on experimental set-up, calibration, and new methods of data analysis presents best practices in experimentation and discusses the principles of calibration in reference to the latest IUPAC guidelines simplifies data analysis and interpretation and covers recent methods by pioneering researchers on the topic utilizes case studies to highlight specific applications discussed in the text covers current techniques in stability testing, screening, and storage temperature stability assessment. Pharmaceutical Isothermal Calorimetry discusses the application of isothermal calorimetric techniques to challenges encountered during the rational design and development of novel drugs and drug delivery systems. Providing a comprehensive review of recent research and trends, this book contains an expert discussion of research and applications to pharmaceutical characterization and formulation. 376 pp. ISBN: 0849331552. $199.95
Encyclopedia of Pharmaceutical Technology, Third Edition - 6 Volume Set (Print) James Swarbrick. 2006. Bringing together acknowledged leaders from every specialty related to pharmaceutical technology, this Third Edition stands as an indispensable and single-source reference at the forefront of pharmaceutical technology and research keeps pharmaceutical professionals and researchers at the cutting-edge of their disciplines with more than 70 NEW entries on topics of utmost importance in the field including advances in systems validation, processing techniques, patent issues, noninvasive drug delivery, and the commercialization of drugs and dosage forms provides a comprehensive overview of most specialty and subspecialty topics relating to the research, manufacture, marketing, and use of pharmaceuticals offers a reader-friendly and timely collection of references to the pharmaceutical market contains an abundance of articles on pharmaceutics, pharmacokinetics, analytical chemistry, quality assurance, drug safety, and manufacturing processes. Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to come, the Third Edition will offer completely new entries that cover critical issues in the field such as the impact of genomics, biotechnology, and implants on drug discovery, targeting, delivery, and formulation. In addition, it will address new regulatory issues, such as the changes in advertising regulations, and emerging FDA procedures. 5536 pp. ISBN: 084939399X. $3,495.95
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries: Second Edition. Syed Imtiaz Haider. 2006. Expertly leading readers through the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry, this source provides 139 ready-to-use Master Validation procedures, template protocols, and reports supplies a CD-ROM with a template of customizable validation standard operating procedures includes examples of 11 critical qualification and re-qualification reports presents 14 exclusive environmental performance evaluation procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States includes step-by-step guidelines for translating GMP requirements into action. Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control. 1144 pp. ISBN: 0849395291. $269.95
Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, Sixth Edition. Series: Drugs and the Pharmaceutical Sciences Volume: 169. Joseph Nally. 2006. Building on the solid foundation of the Fifth Edition and previous editions, this Sixth Edition provides readers with fundamental knowledge of CGMP regulations and current industry applications and practices. Each chapter has been updated and this text supplies new and must-have information regarding the latest FDA guidance documents quality systems approach risk analysis and management. includes:
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. Number of Pages: 700. ISBN: 0849339723. $169.95
Pharmaceutical Photostability and Stabilization Technology. Series: Drugs and the Pharmaceutical Sciences Volume: 163. Joseph T. Piechocki & Karl Thoma. 2006. This guide assists in the selection of the most appropriate photon source and actinometer for specific applications devotes an entire chapter on the study of chemical actinometry-a stable, self-standardizing method of radiation dosage assessment focuses attention on molecular mechanisms and kinetics and their importance in the development of protective measures offers reviews of the available testing chambers for pharmaceutical photochemical studies details protective methods for all dosage forms useful in preventing photodegradation includes information on the use, action, and methods of determination of the effectiveness and stabilization of sunscreens. Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background in the scientific principles involved in photostability testing. Presenting the advantages and disadvantages of various procedures so the reader can select and utilize the most appropriate technique best-suited to their needs, this source includes references to current literature in the field and offers an opinion on future opportunities and challenges. Number of Pages: 445. ISBN: 0824759249. $199.95
Laboratory Auditing For Quality and Regulatory Compliance. Publication Date: 6/20/2005. Donald Singer, Raluca-Ioana Stefan & Jacobus van Staden. Series: Drugs and the Pharmaceutical Sciences Volume: 150. Completely revised and expanded, this up-to-date source assists in the assessment of laboratory procedures in preparation for an external auditor; reflects the impact of computers and information technologies on data generation, analysis, and storage; offers a global perspective on laboratory management and quality control; serves as a comprehensive guide to the design of an effective audit for enhanced laboratory operation. Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance. Number of Pages: 352. ISBN: 1574445707. List Price: $139.95
Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation. Publication Date: 5/26/2005. Stanley Nusim. Series: Drugs and the Pharmaceutical Sciences Volume: 151. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute the manufacturing of quality APIs; studies the process development task, as well as plant design, construction, and operation; reviews the latest regulatory standards in this rapidly changing market; details validation procedures for bulk pharmaceutical chemicals discusses the unique aspects of the quality function in the API industry. Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety. Number of Pages: 368. ISBN: 082470293X. List Price: $139.95
Pharmaceutical Stress Testing: Predicting Drug Degradation. Publication Date: 6/21/2005. Steven W Baertschi. Series: Drugs and the Pharmaceutical Sciences Volume: 153. Richly illustrated and extensively referenced, this source details the execution and interpretation of small molecule stress testing studies; provides a comprehensive overview of the major aspects of the prediction of drug degradation; presents up-to-date approaches to pharmaceutical stress testing discusses the historical context and regulatory framework of stress testing; critically addresses currently utilized methodologies and experimental designs; addresses difficult problems such as mass balance, analytical limitations, and drug-excipient interactions; examines major mechanisms of degradation chemistry in the context of common functional groups; offers alternative approaches to the study of drug stability and degradation with computational approaches and microcalorimetry contains special coverage of freeze-drying processes; provides quick reference to the problems frequently encountered by pharmaceutical researchers. The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature. Number of Pages: 488. ISBN: 0824740211. List Price: $199.95
Polymeric Drug Delivery Systems. Glen S Kwon University of Wisconsin, Madison, Wisconsin, USA. Series: Drugs and the Pharmaceutical Sciences Volume: 148. Publication Date: due May 2005. Offering specific examples of polymeric drug delivery systems that have entered clinical trials or clinical practice, this handbook contains; -a comprehensive historical perspective on N-(2-hydroxypropyl)methacrylamide copolymer conjugates; -innovative approaches for oral drug delivery based on hydrogels; -a critical summary of the development of biodegradable polyanhydrides for local chemotherapy of brain tumors; -the latest advances to improve protein stability in biodegradable microspheres; -critical issues concerning nanoparticulate delivery systems for cancer vaccines; -a detailed examination of polymeric micelles for the targeting of anticancer drugs; -an in-depth summary of synthetic efforts toward graft copolymers for gene delivery; -the latest developments in self-assembling polymers for gene delivery. Emphasizing four major classes of polymers for drug delivery-water-soluble polymers, hydrogels, biodegradable polymers, and polymer assemblies-this reference surveys efforts to adapt, modify, and tailor polymers for challenging molecules such as poorly water-soluble compounds, peptides/proteins, and plasmid DNA. Number of Pages: 680. ISBN: 0824725328. List Price: $199.95
Write it Down: Guidance for Preparing Effective and Compliant Documentation, Second Edition. Janet Gough Industry Consultant, Flanders, New Jersey, USA. Publication Date: 3/30/2005. Includes: -examples for clinical trials; -Provides specifics of writing documentation for regulatory purposes; -Gives examples of reports as well as process, periodic, and progress reports. This book covers writing for the FDA as it applies to the pharmaceutical industry. It presents a brief overview of the regulatory environment and documentation requirements, identifies the roles of writers and readers, and discusses the purpose of good documentation. The book offers documents and representative writing samples from throughout the industry, ranging from the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to complete writing tasks effectively. This new edition includes examples of various forms of representation of data and other illustrative materials that accompany documents needed by the FDA. Number of Pages: 504. ISBN: 0849321719. List Price: $229.95
Dictionary of Drugs on CD-ROM. C.R. Ganellin University College London, UK & David J Triggle State University of New York at Buffalo, USA. Publication Date: 3/29/2005. Presenting over 12,300 entries with accurate, up-to-date and concise information on 45,722 compounds, Dictionary of Drugs on CD-ROM is a one-stop resource for the medicinal chemist. As well as chemical and structural data, this database also offers mechanisms of drug action, octanol/water partition coefficients, marketing status plus literature references to pharmacological studies. In addition - for the top 1500 drugs - monographs are hyperlinked from the renowned PDR® (Physician's Desk Reference) Generics™, providing a wealth of pharmacokinetic and pharmacological data:
System requirements: Pentium II processor or higher, 32 MB Ram, 40 MB hard disk space, 24x speed CD-ROM drive, SVGA monitor at 800x600, 256 colours, Windows® 98, NT 4.x, 2000 or XP. ISBN: 0412787601. List Price: $1,595.00
Metabonomics in Toxicity Assessment. Donald G Robertson Pfizer Global Research & Development, John Lindon Imperial College London, Jeremy K Nicholson Imperial College London & Elaine Holmes Imperial College London. Publication Date: 3/1/2005. Providing essential tools for the toxicologist utilizing metabonomic technologies, this guide presents a clear outline of the use of metabonomics in the safety assessment of new chemical entities; includes equipment and logistical considerations for conducting metabonomic studies from both analytical and biologic perspectives; offers an abundance of figures and tables throughout the text for clear layout of key topics; contains a large amount of references for further research on the topic; presents numerous examples of a wide array of target organs; furnishes in-depth discussions of confounding physiologic variables; covers environmental applications of metabonomic technology; analyzes NMR equipment and instrumentation important to functional metabonomics laboratories. Filling a gap in the literature, this reference provides comprehensive coverage of all aspects of metabonomics technology including analytical and biologic considerations, as well as sections on chemometrics-devoting entire chapters to critical topics such as biomarkers, metabolite identification, and the use of magic angle spinning for tissue metabonomics. Number of Pages: 536.ISBN: 0824726650 List Price: $199.95
Drug Delivery to the Oral Cavity: Molecules to Market. Tapash K Ghosh The Food and Drug Administration, Rockville, Maryland, USA & William Pfister Robbinsville, New Jersey, USA. Series: Drugs and the Pharmaceutical Sciences Volume: 145. Publication Date: 2/28/2005. Emphasizing the impact of intraoral drug delivery and its advantages over conventional oral dosage forms, this handbook covers the latest research concerning drug delivery to the oral cavity, and examines the basic structure, function, biochemistry, and permeability of the oral cavity; analyzes the unique features and optimization of various intraoral drug delivery systems; studies quick, slow, and nondissolving intraoral dosage forms; explores practical and applied aspects of pharmaceutical development for new solid-stage dosage forms for intraoral drug delivery; highlights dozens of oral mucosal delivery systems targeted at the personal care market including quick dissolving films and dentifrice products containing antibacterial agents, fluoride, and flavoring agents; provides a comprehensive appendix of various companies developing intraoral dosage forms and novel delivery system technologies; offers a detailed overview of the wide array of currently available intraoral drug products for the treatment of systemic diseases, as well as products for local treatment of halitosis, bacterial infections, periodontal disease, and other conditions of the mouth; provides an in-depth discussion of recently commercialized drug products for angina pectoris, moderate to severe pain, and smoking addiction. With contributions from recognized authorities in industry, academia, and government, this reference presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market. Number of Pages: 448. ISBN: 0824782933. List Price: $189.95
FDA Administrative Enforcement Manual. Florence R Parker Drug Regulatory Affairs Institute, Pennsylvania, USA. Publication Date: 2/18/2005. Discusses the FDA Administrative Enforcement's authority, detailing what they can and cannot do; Explores the options firms have when faced with FDA Administrative Enforcement actions; Includes case studies to illustrate the 10 FDA enforcement areas and actions; Contains examples of real enforcement letters, injunctions, consent decrees, and other examples of FDA enforcement activities; Delineates practical, hands-on methods to resolve diversified pharmaceutical problems; Presents single-source coverage of all regulated areas cGMP, GCP, GLP, advertising and promotional literature and FDA Administrative Enforcement avenues.
When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought. Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them.
The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities. Number of Pages: 480. ISBN: 084933067X. List Price: $169.95
Encyclopedic Reference of Immunotoxicology. Vohr, Hans-Werner (Ed.).
Due 2005. This work provides rapid access to focused information on topics of
Immunotoxicology not only for scientists and those dealing with laboratory
aspects but also for lecturers and advanced students. Over 200 contributing
authors – including many of the world’s top specialists – have contributed full
essays on all relevant topics, supplemented by keyword definitions of related
terms. Full essays are structured uniformly to provide reader-friendly
information on all aspects of Immunotoxicology, including methods of testing and
analysis, characteristics of substances, the regulatory environment and the
relevance of these to humans. The single A–Z format of both types of entry makes
this reference book very easy to use. The complimentary complete CD-ROM version
provides additional search facilities. The Encyclopedic Reference of
Immunotoxicology is intended to be a comprehensive work of reference which will
provide easy access to relevant information in the fast-growing field of
Immunotoxicology. Approx. 900 p. 200 illus. With CD-ROM., Hardcover. ISBN:
3-540-44172-7. $299.00
Applying Genomic and Proteomic Microarray Technology in Drug Discovery.
Robert S Matson. 12/2004
Microarray technology, more commonly known as small spots, has proved a success when employed in DNA array-based genomic analysis. It is now beginning to be employed in protein tissue array analysis; and as microarray continues to be adopted, it is important that researchers grasp the fundamental principles behind it, as well as, the strengths and limitations. This highly informative book written by a leader in the field introduces the fundamentals of microarray technology, then goes on to describe and evaluate the use of microarray technology in genomic and proteomic applications, and provide practical tips on how to employ the technology in drug discovery and development. 256 pp. ISBN: 0849314690. List Price: $149.95
Analytical Techniques for Biopharmaceutical Development. Roberto Rodriguez-Diaz, Tim Wehr & Stephen Tuck. February 2005. Examining methods to ensure the purity, potency, quality, and performance of drug compounds, this handbook provides
This reference assists scientists in the selection and application of analytical techniques for biopharmaceutical identification, formulation, and assessment-providing a valuable survey of exploratory methods commonly utilized during the preclinical, clinical, and commercial phases of development. Number of Pages: 412 pp. ISBN: 0824726677. List Price: $199.95
Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids. Ram I Mahato. 12/2004.
Newcomers to the field of biopharmaceuticals require an understanding of the basic principles and underlying methodology involved in developing protein- and nucleic acid-based therapies for genetic and acquired diseases. Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids introduces the principles of polymer science and chemistry, as well as the basic biology required for understanding how biomaterials can be used as drug-delivery vehicles. No book to date combines a discussion of high-tech biomaterials-based delivery of protein and nucleic acid drugs with the pharmaceutical or biocompatibility aspects. Featuring contributions from leading experts from around the world, this text discusses physiochemical parameters used for design, development, and evaluation of biotechnological dosage forms for delivery of proteins, peptides, oligonucleotides, and genes. The authors also present biological barriers to extravasation and cellular uptake of proteins and nucleic acids. Combining an introduction to biomaterial delivery with the latest developments in the field, this is a valuable reference for both the novice student and the practicing scientist on delivery of biomaterials, on biomedical polymers, and on polymer therapeutics. Understanding these core fundamentals is critical to moving on to more advanced study. 712 pp. ISBN: 0849323347. List Price: $189.95
Calibration
in the Pharmaceutical Laboratory.
Tony Kowalski. 2001.
Increasingly, pharmaceutical scientists must not only be specialists in their
field but must also be familiar with legislation that governs the use of
equipment in their industry. The regulation of test and measuring equipment
changes continually as new regulations are introduced and new equipment is
developed. Calibration in the Pharmaceutical Laboratory provides general
background on laboratory balances and precision scales, insight into mass
measurements and associated errors, and detailed information on key quality
issues associated with weighing. Managers responsible for QC and QA will find
this book an invaluable tool when setting out SOPs for balances and scales used
throughout the manufacturing and testing process. Key Features: Provides insight into mass measurement and associated errors
• Explains how to establish an acceptable level of confidence in the test
and measuring equipment being used • Surveys current good practice in software engineering and relates this
practice to application involving scientific instruments • Contains detailed information on key quality related issues
• Includes contributions from international experts in the field • Presents the latest GLP/GMP/ISO 9000 standards.
336 pp.
ISBN 1574910922 $229.95
Cell Adhesion. Series : Handbook of Experimental Pharmacology , Vol. 165. Behrens, Jürgen; Nelson, W. James (Eds.)2005. This book provides an overview of the main topics of current cell adhesion research including structural analyses of cell adhesion molecules and studies to their functional role in vitro and in vivo. The present volume focuses on the four major families of cell-adhesion receptors, i.e. the cadherins, the integrins, the Ig-superfamily and the selectin-based adhesion system which are discussed in detail by numerous experts in the field. Keywords: Cadherins, Cell adhesion,Ig superfamily, Integrins, Signaling. X, 481 p. 59 illus., Hardcover. ISBN: 3-540-20941-7. $389.00
21 CFR 11: Complete Guide to International Computer
Validation Compliance for the Pharmaceutical Industry.
Orlando Lopez . due Jan 2004.
Covering regulatory requirements
stipulated by the FDA, this book delineates the organization, planning,
verification, and documentation activities and procedural controls required for
compliance. The author introduces appropriate supporting technologies such as
encryption and digital signatures and places regulatory compliance within the
context of quality assurance. He demonstrates the importance of integrating
validation activities into the system lifecycle using a structured top-down
approach. The material is presented through practical applications of quality
assurance and engineering techniques as they relate to the development of
systems fit to meet user and regulatory requirements. Key Features: Provides a practical approach to computer systems implementation and
operational life project management including activities relevant to
compliance with Part 11 • Presents computer validation within the context of regulated operations
• Discusses regulatory requirements and furnishes the foundation of the
computer systems validation approach • Includes practical examples of applying regulatory requirements
• Covers training, security, user or data authentication, and access control.
264 pp.
ISBN 084932243X $179.95
Cleanroom Microbiology for the Non-Microbiologist, Second Edition. David M Carlberg. 10/2004.
Written for the professional who has an immediate need for the information
but has little or no training in the subject, Cleanroom Microbiology for the
Non-Microbiologist, Second Edition introduces principles of microbiology. It
explains the consequences of microbiological contamination, what contamination
is all about, how microorganisms grow, and how they can be controlled. The
author introduces the vocabulary of microbiology and the types, sources,
control, and elimination of organisms encountered in the manufacture of sterile
products. Beginning with a discussion of the various types of organisms, the
text then covers applications for bacterial detection, avoidance of
contamination, cleanroom design considerations, and validation of disinfection
methods.
New topics covered include:
· International cleanroom standards
· Application of rapid, automated methods for detecting and identifying
microbial contaminants
· In-depth examination of the role of biofilms in pure water systems
· Increased coverage of production of therapeutic products derived from live
tissues and cells
Number of Pages: 216 pp. ISBN: 084931996X. List Price: $139.95
Clinical Studies Management: A Practical Guide to Success.
Simon Cook et al.
due Jan 2004.
This comprehensive desk reference provides an easy-to-read guide to the
practical skills and methods required by project managers running clinical
studies. With a framework based on seven core themes: goals, budgets, time,
resources, measurement, communication and training, this guide is a solid review
of how modern management theory can be brought to bear on the specialist demands
of clinical trials. Chapters include the R&D process, CROs, the Clinical
Study Team, and QA audits. The book presents true-life case histories as well as
a comprehensive overview of drug development processes and trends that are
driving change. It is a resource for anyone who wishes to sharpen their study
management skills. Key Features: Covers the principles of Good Clinical Practice Guidelines
• Integrates R&D into the clinical study sequence and models how to
write a study protocol • Offers anecdotal and visual examples with easy-to-remember reference
points • Presents a comprehensive overview of the drug development process and the
trends that are driving change • Includes analysis of interactions between sponsors and CROs as well as a
profile of the ideal project manager • Presents stand-alone chapters on key topics. 128 pp.
ISBN 0849320844 $119.95
The
Combined Chemical Dictionary On CD-ROM.
John Buckingham. 2000.
Users can now perform convenient time-saving searches across six dictionaries as
a single database. Spanning the breadth of chemistry, more than 489,000
compounds contained in over 197,000 entries can be accessed in seconds with
powerful searching by text, substructure, or a combination of both. Key
Features: Streamlined new interface enabling simultaneous text and structure
searching • New customizable report formats giving you the data you need, the way you
want to see it • Updated every 6 months • Superb quality onscreen display of text and chemical structures
• Available as a single-user or network version. The Combined Chemical Dictionary on CD-ROM provides all entries formerly
available on one or more of the following discs: Dictionary of Organic Compounds (246,000 compounds); Dictionary of Natural Products (177,000 compounds); PharmaSource (38,000 compounds); Dictionary of Inorganic and Organometallic Compounds (101,000 compounds); Dictionary of Carbohydrates (20,000 compounds); Dictionary of Analytical Reagents (14,000 compounds). System requirements: Pentium II processor or higher, 32 MB RAM, 40MB hard
disk space, 24x speed CD-ROM drive, Windows 95, 98, 2000 (from version 4:2
onwards) or NT 4.x, SVGA monitor at 800x600, 256 colors. 35000 pp.
ISBN
041282020X $7995.00
Computer Systems Validation.
Quality Assurance, Risk Management, &
Regulatory Compliance for Pharmaceutical & Healthcare Companies.
Guy
Wingate. Dec 2003.
Both pervasive and ubiquitous, computerized systems are now an integral
component of every corporate strategy in pharmaceutical and healthcare
companies. However, when technology is combined with high-risk public safety
projects or the production and control of life-saving medicines or devices, it
is necessary to ensure that it is reliable, quality assured, and validated.
The most comprehensive guide on computer validation currently available,
containing more than 200 illustrations and more than 100 tables, Computer
Systems Validation helps you see the big picture. The author reviews
regulations and their development, organization responsibilities, validation
life cycle based on GAMP4 Guide, strategic approaches to validation,
electronic records and signatures, handling regulatory inspections, metrics,
and opportunities for performance improvement. He presents practical
examples and checklists throughout the book and explores the role of quality
assurance and risk management as key components of pragmatic regulatory
compliance. Covering methods that help you avoid duplicating effort among
departments and business functions, the book demonstrates how you can use
your investment in technology to improve business efficiency and gain the
competitive edge. Key Features: Contains 24 case studies illustrating the practicalities of validating
different types of computer systems supporting laboratories • Discusses GCPs, GLPs, GMPs, GDPs, and Medical Device regulations from
around the world, with explanations of the latest regulatory developments
from the US FDA • Supplies comprehensive coverage of computer validation principles and how
to put them into practice. 1016 pp.
ISBN 0849318718 $499.95.
Dictionary
of Commonly Cited Compounds 2001.
Dictionary of Commonly Cited Compounds on CD-ROM is a carefully edited
database containing the 25,000 most frequently cited compounds used by chemists.
It contains the top 25,000 most commonly cited compounds in Chemical Abstracts
(excluding polymers and biologicals) in Chapman & Hall chemical dictionary
format with chemical names, CAS numbers, bibliographic references, physical
properties, and chemical structures. Fully substructure searchable, this easy to
use database enables rapid retrieval of concise chemical and bibliographic data
on the most commonly used chemicals. It covers organic compounds, inorganic
compounds, drugs, natural products, materials, alloys, the elements, and their
isotopes. Key Features: Streamlined search interface enabling simultaneous text
and structure searching • Customizable report formats giving you the data you
need, the way you want to see it • Superb quality onscreen display of text and
chemical structures· Available as a single user or network version. System requirements: Pentium II processor, running Windows™ 95, 98, 2000,
NT4.x, 16MB RAM, 12 MB free hard disk space, 24x CD-ROM drive.
ISBN 1584882514
$84.95
Directory of Approved
Biopharmaceutical Products. Stefania Spada & Gary Walsh.
8/27/2004. Provides a brief overview of each biopharmaceutical approved in the
US and by centralized European drug approval system in the EU; Outlines the
properties of each drug in consistent monograph format; Includes information
from both regulatory agencies and pharmaceutical companies; Indexes drugs both
by brand name and by biological activity. Biopharmaceuticals, the term for
genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic
acid-based products, have become an increasing part of the pharmaceutical
armament. While this category of drugs accounts for approximately 25% of all new
drugs coming to market, very few references exist that review these commercially
available products. Until now, accessing data on the list of currently approved
biopharmaceuticals has been laborious and patchy. Directory of Approved
Biopharmaceutical Products brings together key information on various aspects of
these compounds, presenting a brief summary of each biopharmaceutical currently
approved for medical use. Each summary includes the scientific and trade name,
year and regions approved, approved indications, manufacturer, marketing right,
method of manufacture, scientific overview, and therapeutic properties. Based on
information gathered from regulatory agencies and pharmaceutical manufacturers,
the book presents the most comprehensive data currently available in a single,
convenient volume. This comprehensive and consistent approach will save
professionals in the pharmaceutical industry hours spent trawling the literature
- and provides a singular resource for future reference. 336 pp. ISBN:
0415263689. $159.95
Drug
Delivery Systems. 2nd edition.
Pharmacology & Toxicology series: Basic & Clinical Aspects Volume 4.
Vasant V. Ranade & Mannfred A.
Hollinger. 2003.
Drug delivery technologies represent a
vast and vital area of Research and Development. The demand for innovative drug
delivery systems continues to grow, and this growth continues to drive new
developments. Building on the foundation provided by the first edition, this
title covers the latest developments in both industry and academia. Key
Features: Covers the latest developments in all areas of drug delivery systems • Presents the information in a simple, straightforward, clear, and concise
manner • Provides a global perspective for present and future advances and market
opportunities • Contains input from Wall Street and other global financial institutions
• Includes strategies for dealing effectively with regulatory agencies
around the world. New in this edition: Chapter focusing on novel technologies and their global outlook
• Coverage of electronically controlled drug delivery • Macrocapsules and nanoparticles in drug targeting
• Drug nanocrystals and other new delivery systems • Updated information on liposomes as carriers. Written in a straightforward, clear, and concise manner, the author provides
a global perspective on current and future advances and market opportunities.
Drug Delivery Systems, Second Edition answers the need for comprehensive
information in a single resource for anyone venturing into this area of drug
development. 464 pp.
ISBN 084931433X $179.95
Drug Discovery and Evaluation. Pharmacological Assays. Vogel, Hans G. (Ed.). 2nd, completely revised, updated, and enlarged ed., 2002. Now expanded and updated to include molecular biology and genetic engineering techniques! The 2nd edition of this successful reference book contains a comprehensive selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Effects covered include cardiovascular, analgesic, endocrine, psychotropic respiratory, renal and immunomodulatory activities. Each of the more than 1000 assays comprises a detailed protocol outlining the purpose and rationale of the method, a critical assessment of the results and their pharmacological and clinical relevance. The enclosed and fully searchable CD-ROM allows easy identification of specific tests. An appendix with up-to-date guidelines and legal regulations for animal experiments in various countries will help the reader to plan experiments more effectively. XLIV, 1408 p. With CD-ROM., Hardcover. ISBN: 3-540-42396-6. $165.00
Electronic Record Keeping:
Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160,
162, and 164. David Nettleton & Janet Gough. 12/29/2003
" Provides in-depth coverage of CFR 45, and CFR 21 Part 11, and HIPPA regs 160,
162, and 164
" Reproduces relevant section of the regs and provides comment on what they mean
in terms of industry standard
" Covers how to evaluate, select, and implement an e-system
" Explores how to establish and maintain security and accountability
The current revolution in software, and the regulations that have evolved to
address it, have increasingly caused companies to turn to off-the-shelf software
for electronic record keeping. Data captured in computerized systems must be as
reliable, if not more so, than data on paper. Electronic Record Keeping:
Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
explores how to evaluate, select, implement, and document an e-system that will
keep your organization in compliance. Covering Title 21 of the Code of Federal
Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts
160, 162, and 164 of the Health Insurance Portability and Accountability Act (HIPAA),
this book provides guidance for selecting, purchasing, installing, validating,
and managing commercial off-the-shelf software for data collection and
retention. It takes a number of years for industry standards for a new
regulation to develop from dialog between companies and the regulating agency.
These standards are in place for Part 11, which was passed into law in 1997.
Healthcare providers who must implement electronic record keeping can learn how
to best do it by understanding the parallel between the new HIPAA regulations
and the industry standards for Part 11. Further, certain FDA-driven activities,
such as patient record keeping in clinical trials, now must comply with the new
HIPAA regs as well. To help companies achieve and maintain compliance, the
authors cover audit trails, validation, documentation, training, and security
and accountability. They discuss what the regulations say and what they mean.
Compliance may be mandatory, but it also makes good business sense. Companies
that are compliant will always be poised to move forward, and they will avoid
the grief that comes from poor or faulty record keeping and documentation. This
book gives you the tools you need to keep your company both compliant and
competitive. 384 pp. ISBN: 0849321646. $299.95
Encyclopedic Reference of Molecular Pharmacology. Offermanns, Stefan; Rosenthal, Walter (Eds.). 2004. This comprehensive encyclopedic reference provides rapid access to focused information on molecular pharmacology for research scientists, clinicians and advanced students. With the A-Z format of about 2000 entries, about 200 authors provide a complete reference to the area of molecular pharmacology. The book combines the knowledge of classic pharmacology describing drug action as well as the more recent approach of the precise analysis of the molecular mechanisms by which drugs exert their effects. Short keyword entries define common acronyms, terms and phrases. In addition, detailed essays provide in-depth information on drugs, cellular processes, molecular targets, techniques, molecular mechanisms and general principles. Each essay is well-structured, with extensive cross-referencing between all entries. The book is accompanied by a CD-ROM which provides the full text and facilitated searches. XXII, 1116 p. 302 illus. 136 tabs. With CD-ROM., Hardcover. ISBN: 3-540-42843-7.$270.00
FDA Administrative Enforcement Manual. Florence R Parker . February 2005.
The FDA Administrative Enforcement Manual is a self-contained single source complete with pertinent references and practical outlines for policies and procedures to understand and comply with U.S. drug development and manufacturing regulations. It explores the control of drug research and the manufacturing industry, introduces basic industry experience and techniques, and presents a practicum for applying the theory to everyday problems. The book covers the 10 critical administrative enforcement areas, including recall, application integrity, injunction, seizure, and more, then supplements the topics with regulations, lawsuit case studies, enforcement information, and reference material. 456 pp. ISBN: 084933067X. List Price: $169.95
FDA Regulatory Affairs: A Guide for
Prescription Drugs, Medical Devices, and Biologics. Douglas J
Pisano & David Mantus. 12/23/2003
" Provides a road map to the FDA and drug, biologic, and medical device
development
" Offers current, real time information in a simple and concise format
" Contains a chapter highlighting the new drug application (NDA) process
" Discusses FDA inspection processes and enforcement options
" Includes contributions from experts at companies such as Millennium, Genzyme,
leading CROs such PAREXEL, Biologics Consulting Group, and the FDA
Since the enactment of the first drug law in 1848, the legislation surrounding
drug development has evolved into a maze of regulations that can be hard to
navigate. Not only are existing regulations constantly reviewed and updated, the
increasingly rapid rate of development in the pharmaceuticals field creates new
issues that need to be addressed by new legislation. Written in plain language
without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for
Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the
myriad and sometimes confusing regulations that govern this constantly changing
field. The book examines the pertinent aspects of the Federal Food, Drug, and
Cosmetic Act as they apply to human drug and device development, research,
manufacturing, and marketing. It focuses on the new drug approval process, cGMPs,
GCPs, quality system compliance, and the corresponding documentation
requirements. Although there are a number of references on these topics, this
book is unique in that it is written in a general, easy to read prose style. It
presents information drawn from a wide range of resources in a single, easy to
use format. FDA approval can be a lengthy and expensive process. In order for a
pharmaceutical manufacturer to place a product on the market for human use, a
multiphase procedure must be followed. Providing a reference for students,
professionals, and especially those who are charged with the day-to-day tasks of
assuring regulatory compliance under FDA guidelines, this book demystifies the
inner workings of the FDA and allows you to understand how it operates with
respect to product approval. 376 pp. ISBN: 1587160072. $149.95
FDA-Speak: A Glossary and Agency Guide.
Dean E. Snyder. 2001.
Often
thought of as a subdialect of American "governmentese," FDA-Speak is a
language unique to healthcare regulators and those regulated. If you have any
involvement with the US Food and Drug Administration, or if they have
involvement with you, you need to speak the language. This revised and updated
edition of FDA-Speak retains the original easy-to-use glossary format, but now
includes more than three times the number of entries in the first edition,
defining more than 2,500 acronyms and technical/regulatory words to which the
FDA has applied its own distinctive meaning. FDA-Speak provides the definitive
listing of all of the regulatory words, phrases, and acronyms important to
development, manufacture, quality control, marketing, import/export, and
registration of pharmaceuticals, diagnostic products, medical devices, software,
veterinary products, biologics, nutrition and dietary supplements, and bulk
chemicals. Don't miss the all-new section of appendices that will guide you to
information you need on the FDA website. Appendices include:
Laws Enforced by the FDA • FDA Organization Charts and Contact Information • FDA
Field Operations Index and Inspection Guides • FDA Forms • FDA Guidance
Documents • DSMA Staff Directory. 369 pp.
ISBN 1574911295 $199.95
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their
Suppliers. 6th edition.
Standardizes
audits and minimize subjectivity amongst auditors.
Two volume set:
ISBN 0849318491 $499.95
Volume 1: With Checklists and Software Package.
Leonard Steinborn. June 2003.
Provides a complete set of checklists for internal and
contract device and drug manufacturers and developers, contract software
developers, and suppliers of chemical, printed material, electronic
component, and general supplies. It also includes a simulated QSIT audit,
and a new-product market launch. All of these are referenced to the relevant
relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The
text also explains various audit types, do's and don'ts for auditors, and
guidance for audit preparation, performance, conclusion, report derivation,
and follow up activities. A CD-ROM packaged with the book contains all of
the checklists in a customizable electronic format. 448 pp.
ISBN
0849318467 $299.95
Volume 2: Regulations, Standards, and Guidelines.
Leonard Steinborn. Nov 2004.
Standardizes audits and minimize
subjectivity amongst auditors. Provides easy, objective, and quantifiable
results for management track and trend compliance. Assures comprehensive
auditing of all facets of applicable regulations and standards. Enables
auditors to easily trace checklist questions to the requirements in
preparation for closing meetings. Volume 2 of this set contains the full
text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards
referenced in the checklists furnished in Volume I. The book is presented in
an convenient, easy-to-read format, organized to provide fast access to the
guidelines and regulations of interest. 440 pp.
ISBN 0849318475 $299.95
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance.
John Sharp. 2004.
With over twenty different official regulatory statements worldwide on Good
Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products,
two stand out as being the most influential and most frequently referenced.
Bridging the gap between U.S. regulations and European Good Manufacturing
Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and
Compliance gleans the most important substance from the U.S. Current Good
Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European
Guide to Good Manufacturing Practice for Medicinal Products for Human and
Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience
in technical management, production, quality assurance, and distribution within
the pharmaceutical industry, offering a hands-on guide to better understand and
implement optimal pharmaceutical practices. This book also compares the
principle requirements of GMP, and explores the reasoning behind these
requirements and ways to comply with them. Relevant topics include personnel,
documentation, premises and equipment, production, quality control,
self-inspection, recalls, and more. This is an essential guidebook for those who
wish to expand their pharmaceutical business in any international capacity. 520
pp. ISBN: 0849319943. List Price: $229.95
Good Design Practices for GMP Pharmaceutical Facilities. Andrew Signore &
Terry Jacobs. Series: Drugs and the Pharmaceutical Sciences Volume: 146. March
2005. This handbook
AUDIENCE: A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces. Number of Pages: 640 pp. ISBN: 0824754638. List Price: $199.95
Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products (Volume 4 of 6). Sarfaraz K Niazi. 2004.
The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products. 288 pp. ISBN: 0849317495. $295.95
Handbook of Pharmaceutical Manufacturing Formulations. by Sarfaraz K Niazi
Therapeutic Proteins Inc., Deerfield, Illinois, USA. 2004.
· Supplies the largest reference on pharmaceutical formulations
· Lists readily accessible formulations as chemical entities, dosage forms or
pharmacological classifications
· Provides substantial time and cost savings in pharmaceutical research and
development
· Covers issues related to generic manufacturing of drugs including cGMP
compliance, pre-approval inspections, stability testing, and more
With exponential growth of generic formulations, the need for ready formulations
has increased. Essentially an authoritative and practical guide to the art and
science of formulating drugs, the six-volume handbook contains the Bill of
Materials and Manufacturing Directions for over 2000 drug formulations,
including a number of biotechnology and patented drugs.
The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications and other sources of generic and proprietary formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations.
Each volume of the series is divided into two parts: the section on regulatory and manufacturing guidelines and the section on formulations. The series covers issues related to generic manufacturing of drugs including cGMP compliance, pre-approval inspections, stability testing, bioequivalence testing, packaging commodity development, changes to aNDAs, SUPAC for equipment, and a large number of other relevant and current topics of interest to the pharmaceutical industry. Each category of drug formulations, classified in separate volumes, is analyzed for the common difficulties in formulating drugs.
This book is the first of its kind published in the pharmaceutical literature and is a must collection for all pharmaceutical manufacturers, educational, and regulatory authorities. Companies with large formulation teams will find this book an excellent platform for benchmarking their own products and generic companies will find this book an excellent source of information prior to embarking on formulating drugs coming off patent. Number of Pages: 2836. ISBN: 0849317525. $1,695.00
International
Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic
Products. 2nd edition.
Charles Sidebottom. 2003.
Extensively revised, with an updated title that reflects its expanded
scope, International Labeling Requirements for Medical Devices, Medical
Equipment, and Diagnostic Products, Second Edition provides the practical
labeling information you need to achieve rapid regulatory approval, gain
marketplace acceptance, and assure user comprehension. A complete guide to all
aspects of advertising, labeling, and packaging, the book explains the relevant
laws, regulations, and requirements in major markets worldwide. Coverage
includes requirements such as text, dimensions, type sizes, graphic elements,
symbols, and language for implantable devices, sterile devices, OTC products, in
vitro diagnostic products, radiation emitting devices, contraceptive devices,
and more. This is not a "cookbook" of easy-to-follow recipes. It is a
comprehensive resource that gives you the tools to stay ahead in the
ever-changing regulatory environment. Key Features: Helps readers obtain rapid regulatory approval and success in the
marketplace • Explains all aspects of advertising, labeling, and packaging in clear,
concise language • Provides explanations of the relevant laws, regulations, and requirements
in major markets worldwide without excess "governmentese" • Uses examples of compliance and noncompliance to demonstrate the concepts
discussed in the text. 616 pp.
ISBN 0849318505 $269.95
Lipospheres in Drug Targets and Delivery: Approaches, Methods, and Applications. Claudio Nastruzzi. 11/29/2004.
Lipophilic drug carriers such as lipospheres and lipid nanoparticles can
modify the in vivo distribution of associated substances. They can therefore be
used to improve the therapeutic index of drugs by increasing their efficacy
and/or reducing their toxicity. If the delivery systems are carefully designed,
lipospheres can help to overcome the delivery problems posed by new classes of
active molecules, such as peptides, proteins, genes, and oligonucleotides. They
may also extend the therapeutic potential of established drugs. With these
powerful abilities, lipid-based nano- and microparticulate carriers are becoming
an increasingly important weapon in the pharmaceutical arsenal. Lipospheres in
Drug Targets and Delivery: Approaches, Methods, and Applications presents an
overview of the most recent applications of lipid-based nano- and
microparticulate carriers in the fields of medicine and biotechnology. It
includes chapters on preparation, characterization, and delivery of lipospheres;
liposphere based vaccines; therapeutic applications to different systems, and
suggestions for further research. With numerous illustrations, tables, and
photographs, this book describes procedures for specific applications and
biological systems and presents lipospheres as a technical solution to various
problems associated with the controlled release of biochemicals. Written for
researchers in medicine and life science, pharmaceutics, and biotechnology, this
book provides in-depth coverage of an important topic in biochemistry, molecular
biology, and drug development. Number of Pages: 184. ISBN: 0849316928. $169.95
The
Merck Index: CD-ROM Windows, Version 12.3.
S. Budavari, et al. 2000.
The Merck Index* has been a trusted reference tool for more than a century,
and it continues to be the premier resource for science and medical
professionals in the new millennium. The need for enhanced resources has never
been greater, and this user-friendly CD helps meet the challenges of the future
by offering easy access to a vast world of information, -- both quickly and
efficiently. Special features include outstanding search capabilities, including
the tools to draw the structure you are interested in ON-SCREEN -- and then
search for it. Text searching is possible in over 27 fields including: Chemical, Common, Generic Names and Trademarks
• Molecular Weights and Formulae • Physical and Toxicity Data • Citations to Scientific and Patent Literature.
Key Features: 100 new monographs supplement the more than 10,430 monographs in Version
12:2 • Extensive updates of many original monographs • Streamlined search screens give you faster access to the data you need
• Fully customizable report options enable you to print results exactly as
you want to see them • Full 32-bit compatibility with Windows NT. 2100 pp.
ISBN 1584881291 $79.95
Microbiological Assay for Pharmaceutical Analysis.
A Rational Approach.
William Hewitt. due Dec 2003.
A user-friendly guide for the evaluation
of microbiological assays, this book provides a lucid explanation of the sources
of error in microbiological assay and helps analysts choose efficient assay
designs that will minimize those sources of error. Beginning with a review of
the theoretical basis for the quantitative aspects, the author discusses
microbiological assay as a branch of pharmaceutical analysis and distinguishes
it from biological assay in general. He draws attention to the microbiological
aspects that may not be so obvious to the chemical analyst and to the analytical
aspects that may not be so obvious to the microbiologist. The book contains
detailed evaluations of assays that illustrate typical experimental designs and
addresses how to present a realistic assessment of the best potency estimate
from a series of assays. Although there are other valuable books available in
this area, they do not address evaluation. It expands on the guidance given in
pharmacopoeias and helps you choose the assay design most appropriate for the
purpose of your assay. Key Features: Explores how to design an efficient assay
that minimizes sources of error • Facilitates real understanding of the validity of an assay rather than
just acceptance of the results of a statistical evaluation • Discusses the criteria for making the decision to accept or reject the
results of an assay • Covers issues of sensitivity, specificity/selectivity, accuracy, and
precision • Illustrates the wide range of experimental designs available to the
analyst and compares their properties • Includes inspection techniques from European and United States
pharmacopoeias. 260 pp.
ISBN 0849318246 $229.95
Microbiological Contamination Control in Pharmaceutical Clean Rooms. Nigel Halls. 2004. Discusses measurement and control of contamination for safe drug manufacturing. Offers logical approaches to problems associated with oral and nasal preparations. Reviews the most common commercial rapid microbiological test methods. Features a chapter on clean room finishes and construction materials - information available nowhere else. Highlights microbial focus of clean room control and the importance of knowledgeable laboratory practices . Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisciplinary approach, Microbiological Contamination Control for Pharmaceutical Clean Rooms neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms. The book helps you satisfy domestic and international regulations and prevent your organization from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This valuable guide brings you up to date on the types of techniques available, the scientific principles that underpin them, and the practicalities and limitations of each. Number of Pages: 200. ISBN: 0849323002. $199.95
Microbial Contamination Control in the Pharmaceutical Industry. Series: Drugs and the Pharmaceutical Sciences Volume: 142. 8/30/2004. Offers comprehensive examination of the literature on the application and implementation of rapid technologies for quality control analysis; Includes chapters by world-renowned authorities on topics including water testing, endotoxins, environmental monitoring, and more. Discusses the limitations of standard analytical methods and the use of alternative technologies to enumerate, detect, and identify microorganisms; Describes and compares the microbiological method and sterility test requirements, pass and fail criteria, and validation procedures of three major pharmacies. Includes examples of suitable quality control programs for water testing; Assesses testing protocols and microorganisms utilized in the validation of disinfectant efficacy; Covers critical factors affecting the preservation of pharmaceutical products. This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions. 328 pp. ISBN: 082475753X. $175.00
Microwave Assisted Organic Chemistry. Jason P Tierney & Pelle Lidstrom. due Fall 2004. Microwave Assisted Organic Chemistry demonstrates the under lying principles of microwave dielectric heating and, by reference to a range of organic reaction types, its effective use in synthetic organic chemistry. The recent introduction of specifically designed and constructed microwave equipment, countering safety, and reproducibility concerns has led to widespread use of microwaves in synthetic organic chemistry. Microwave assisted synthesis is now established in many industrial and academic laboratories giving access to the novel chemistry that can be carried out in a variety of organic reaction types. Case studies, drawn from the pharmaceutical industry, illustrate the impact microwave assisted organic synthesis can have on chemical research. Number of Pages: 320. ISBN: 0849323711. $149.95
Modern
Protein Chemistry: Practical Aspects.
Gary C. Howard & William E. Brown.
2001.
In recent years, interest in proteins has surged. This resurgence has been
driven by the expansion of the post-genomic era when structural genomics and
proteomics require new techniques in protein chemistry and new applications of
older techniques. Protein chemistry methods are used by nearly every discipline
of biomedical research. Many techniques have been used in less traditional ways
with exciting results. Modern Protein Chemistry: Practical Aspects describes the
practical side of advanced techniques in protein chemistry. The book gives
researchers an excellent "cost-benefit" analysis of these techniques. The
contributors have been selected for their prominence in their specific fields
and because they run laboratories that actively collaborate with other
scientists. Researchers and practitioners, both beginners and experienced, who
are looking for new ideas and who are interested in applying these more advanced
methods will be assisted in their work by these commentaries. This guide
provides hands-on information to complement theoretical understanding. The
theory behind these methods can be found in existing books and in the original
literature. However, no other guide will help you make a practical evaluation of
these methods and their value to your work. Key Features: Presents careful
descriptions and critiques of techniques for an overview and cost benefit
analysis • Describes alternate methods to allow for choice by the researcher • Provides hands-on information to complement theoretical understanding. 272 pp.
ISBN 0849394538 $109.95
Pharmaceutical Product Strategy: Using Dynamic Modeling for Effective Brand Planning. Mark Paich, Corey Peck & Jason J Valant . 12/2004
Focusing on cross-functional coordination and knowledge integration, Pharmaceutical Product Strategy: Using Dynamic Modeling for Effective Brand Planning introduces many of the complexities facing many pharmaceutical firms. The book examines issues surrounding utilization of information, consistency of assumptions, and the need for processes that integrate various functional areas. It also discusses why the dynamic modeling process is an effective way to address these problems in a systematic and accessible way. An appendix covers more technical points of dynamic model analysis including agent-based approaches and mathematics of continuous formulations, and details for choice models and conjoint analysis. 328 pp. ISBN: 0849327296. List Price: $159.95
Pharmaceutical Engineering Change Control. 2nd edition.
Simon G. Turner. due
Dec 2003.
While change control can ensure that
developments do not compromise business operations, when dealing with
pharmaceuticals manufacturing, change control must also ensure that developments
do not compromise regulatory compliance. This title gives you the technical and
management skills required to successfully and efficiently employ change control
procedures. Key Features: Examines the basis for developing change control procedures for
pharmaceutical projects • Discusses the importance of integrating change control into quality
management systems • Explores the role computers play in the production of pharmaceuticals
• Covers how to ensure change controls are effectively applied and recorded • Contains case histories that illustrate key points and provide a basis for
change control training. 168 pp.
ISBN 0849320615 $189.95
Pharmaceutical Marketing: A Practical Guide.
Dimitris
Dogramatzis. 2001.
Designed as a practical guide for the pharmaceutical
industry, this book applies cutting-edge marketing concepts and
tools to the real-world intricacies of marketing a heavily regulated product
whose success is determined not by the actual end-user, but by various industry
stakeholders. From creating a worldwide vision that cascades into local tactics
to managing a drug portfolio or pricing a particular product, this book guides
readers through developing, implementing, and auditing a successful marketing
strategy geared specifically to the pharmaceutical industry. It provides graphs,
tables, sample worksheets, pharmaceutical case studies, and a sample marketing
strategy. 400 pp.
ISBN 157491118X $249.95
Photostability Of Drugs And Drug Formulations, 2nd Edition. Hanne Hjorth Tonnesen. 2004. Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features: " Assists non-experts in this field design a test protocol and interpret the results " Covers in vitro and in vivo aspects of interactions between drugs and light " Explores the kinetic and chemical aspects of drug photodecomposition " Discusses the problems frequently encountered in photochemical stability testing " Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs " Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint " Offers specific guidance in photostability testing and screening of drug photoreactivity. Number of Pages: 448. ISBN: 0415303230. $189.95
Polymeric Gene Delivery: Principles and Applications. Mansoor M Amiji Northeastern University, Boston, Massachusetts, USA. 9/29/2004. Describes the different delivery options with polymeric materials; Addresses various challenges to gene delivery using polymeric vehicles; Provides perspectives from both academic research labs and industrial applications. To treat disease or correct genetic disorders using gene therapy, the most suitable vehicle must be able to deliver genes to the appropriate tissues and cells in the body in a specific as well as safe and effective manner. While viruses are the most popular vehicles to date, their disadvantages include toxicity, limited size of genes they can carry, and limited scale of industrial production. This is the first comprehensive book to specifically address polymeric gene delivery systems. Uniting the expertise of international academic and industrial scientists who are working in the area of polymeric vectors for gene delivery, it is written by prominent researchers directly involved in this field. The book is divided into five sections that deal with challenges and opportunities in gene delivery and the efficient delivery of genes into somatic cells using polymeric vectors. The authors discuss using biodegradable polymers, condensing and non-condensing polymeric systems, microspheres and nanospheres, and designing specialized delivery systems based on targeting strategies. This book accentuates the versatility of polymeric delivery systems, including the potential for biocompatibility, the ability to design their formulation and geometry for a specific purpose, and the ease of modification to the surface of polymeric carriers. This book is an up-to-date guide for researchers in the field and those interested in entering this dynamic field. Number of Pages: 704 pp. ISBN: 084931934X. $179.95
Polysaccharides: Structural Diversity and Functional Versatility, Second Edition. Severian Dumitriu. 11/2004
Completely revised and expanded to reflect the latest advancements in the field, Polysaccharides, Second Edition outlines fundamental concepts in the structure, function, chemistry, and stability of polysaccharides and reveals new analytical techniques and applications currently impacting the cosmetic, medicinal, chemical, and biochemical industries. The authoritative book discusses polysaccharides utilized in medical applications such as polysaccharide-based hydrogels, polysialic acids, proteoglycans, glycolipids, and anticoagulant polysaccharides; renewable resources for the production of various industrial chemicals and engineering plastics polysaccharides; and more. 1224 pp. ISBN: 0824754808. $269.95
Practical Pharmaceutical Laboratory Automation.
Brian
Bissett. due 2004.
Laboratory automation is an increasingly important part of the job
description of many laboratory scientists. Although many laboratory
scientists understand the methods and principles involved in automation,
most lack the necessary engineering and programming skills needed to
successfully automate or interface equipment in the lab. A step-by-step,
how-to reference and guide, Practical Pharmaceutical Laboratory Automation
explores the processes needed to automate the majority of tasks required in
research today. The author discusses topics ranging from automated
mathematical analysis to robotic automation of chemical processes, to
combinations of these and other processes. He presents a detailed discussion
of high throughput screening and assay development and takes an in-depth
look at Visual Basic as the primary programming language used in
laboratories. The text has a dedicated web site (http://www.pharmalabauto.com)
which contains all the sample code and examples contained within the text as
well as other information related to laboratory automation. Providing a starting
point for tackling automation problems, Practical Pharmaceutical Laboratory
Automation helps you develop a strategy for automation that gets consistent
results. Key Features: Provides information that can be used to construct simple, low cost,
automatic test systems • Discusses high throughput screenings (HTS) and assay development
Includes practical examples and solutions to real world problems that are
hard to find in other sources • Explores the concepts and methods of
reverse engineering • Helps you set up systems to measure a variety of quantities Provides a
Web site with companion files to the text at http://www.pharmalabauto.com/.
464 pp.
ISBN 0849318149 $189.95
Preventing
Medication Errors and Improving Drug Therapy Outcomes.
A Management Systems
Approach.
Charles D. Hepler & Richard Segal. 2003.
Drug-related illnesses and complications
cost the health care system billions of dollars each year. Medical errors
account for approximately 100,000 deaths each year, and drugs are the most
common cause of medical errors in hospitals. Synthesizing research studies from
seven nations, Preventing Medication Errors and Improving Drug Therapy Outcomes:
A Management Systems Approach explores medications use from a social
perspective. It identifies and describes the preventable adverse outcomes of
drug therapy, discusses the safety, cost-effectiveness, and quality of
medications use from a management systems perspective, and proposes systematic
solutions. Key Features: Discusses drug therapy and medications use from a comprehensive, systems
perspective • Synthesizes selected research from seven countries on adverse outcomes
from the use of medications • Describes what a properly designed and managed drug therapy system would
look like and how the components should fit together • Covers processes for evaluating medication-use systems and identifying and
correcting ineffective system operations • Presents detailed data on patient outcomes and why standards must change
to improve drug safety and effectiveness. Read this book in order to learn: Why medicines often fail to produce the desired result and how such
failures can be avoided • How to think about drug product safety and effectiveness
• How the main participants in a medications use system can improve outcomes
and how professional and personal values, attitudes, and ethical reasoning
fit into drug therapy • What a properly designed and managed medications use system would look
like - specific components, how the components fit together into a system,
and how the system can be maintained and improved • Ways to evaluate medications use systems, how to recognize ineffective
systems operations, how to identify missing system components and how to
correct them • How the environment of medications use affects systems operations and
patient outcomes, and why standards must change to improve drug safety and
effectiveness. 464 pp.
ISBN 084931576X $149.95
Rapid Microbiological Methods in the Pharmaceutical Industry.
Martin Easter & Tom Novitsky.
March 2003.
In recent years there has been increased interest in the possibility of rapid
microbiological methods offering enhanced potential error detection
capabilities. However, these methods raise a number of questions, such as how
to validate new methods, will they be accepted by the pharmacopoeias, and,
most importantly, how will the regulators respond? Rapid Microbiological
Methods in the Pharmaceutical Industry answers these questions and more. Key
Features: Provides the details of a range of rapid microbiological methods, their
applications, and practical tips regarding validation, established use, and
regulatory acceptance • Brings together expert opinion and experience in implementing
microbiological methods and their application in the pharmaceutical industry
• Covers the origins of methods and current issues facing the requirements
of microbiology and its associated test methods • Explores how to seek better, more pragmatic methods for the assessment of
microbiological hazards and risks to ensure product and consumer safety.
Martin Easter and his panel of experts: Describe the range of rapid microbiological methods and their
applications, including practical tips, and their status regarding
validation, established use, and regulatory acceptance • Explore the origins of current methods and the current issues facing the
requirements of microbiology and its associated test methods • Delineate the challenges involved in seeking better and more pragmatic
methods for the assessment of microbial hazards and risks to ensure product
and consumer safety. The book assists you in applying an effective system to assess the real
microbiological hazards and, hence, quantify realistic risks. Additionally, it
provides monitoring methods that will deliver meaningful, useful data for
effective decision making in manufacturing, quality assurance, and product
safety. The expert and authoritative information in this book will help you
find better solutions to ensuring the microbiological safety of pharmaceutical
products. 288 pp.
ISBN 1574911414 $239.95
Safety Pharmacology in Pharmaceutical Development and Approval.
Shayne
C. Gad. 2003.
The Propulsid and Seldane drug disasters could have easily been avoided with
more rigorous safety pharmacology studies of these compounds prior to any
human clinical trials. Unfortunately, safety pharmacology has been
overlooked by all but a few developers. With recent drug withdrawals from
the market and the implementation of the International Conference on
Harmonization (ICH) guidelines, safety pharmacology will become a more
important phase in drug development. Safety Pharmacology in Pharmaceutical
Development and Approval spells out the whys and hows of safety pharmacology
testing. The book covers the background, history, and concerns that have
evolved from lackluster safety pharmacology activities in the past. It
details regulatory requirements, provides comprehensive information on study
designs, and covers both the required battery of studies and the
supplemental, follow-up battery. Until recently, pharmacovigilance has been
product-rather than utilization-oriented and often invisible in clinical
medicine. It is clear that definitive safety pharmacology standards are
needed to combat the increase in adverse reactions seen in the last 20
years. Giving you a head start in this emerging field, Safety Pharmacology
in Pharmaceutical Development and Approval addresses how best to implement
ICH safety standards and how to integrate pharmacology safety evaluations
into existing safety evaluations. Key Features: Presents international perspectives including the activities of the
International Conference on Harmonization • Explains how to integrate safety pharmacology evaluations into existing
safety evaluation studies • Covers the core battery of tests and supplemental testing procedures
• Discusses the principles of safety pharmacology study design and
interpretation and their relevance to man • Provides detailed coverage of this emerging discipline.
208 pp.
ISBN 0849313805 $149.95
Software
Development and Quality Assurance for the Healthcare Manufacturing Industries. 3rd edition.
Steven R. Mallory. 2002.
Completely revised and updated, this
book is a practical guide for anyone involved in all levels of the development
and quality assurance of software programs for healthcare products -
particularly in the medical device and equipment manufacturing industries. From
high-level strategies and mechanics to detailed flow charts, tables, and sample
forms, the text helps assure that all requisite phases of development and
testing have been considered and implemented as readers develop a complete,
integrated, cohesive, and interrelated software quality assurance program.
Readers will learn how to design, implement, and manage the software development
effort, as well as how to audit the program. 532 pp.
ISBN 1574911368
$239.95
Springer Index of Viruses. Tidona, Christian A.; Darai, Gholamreza (Eds.)2001. This comprehensive Encyclopedic Reference systematically integrates the state-of-the-art knowledge on all virus genera in the standardized format of lists, tables and figures. Each chapter provides highly structured and condensed information on a single virus genus and was contributed by one of the worlds leading experts in that particular field. Each of the 241 taxonomically ordered chapters includes detailed information on individual genus members, historical events, virion morphology, genome properties, replication strategy, properties of individual transcripts and proteins, sequence accession numbers, biological properties, diseases, recombinant vector constructs, vaccine strains, key references, as well as a high-resolution particle image and a drawing of the genome organization. Its high content of easily accessible detail information makes this Encyclopedic Reference an indispensable tool for both researchers and lecturers. XLVII, 1511 pp. 434 figs., 1449 tabs., with CD-ROM., Hardcover. ISBN: 3-540-67167-6. $325.00
Transcription Factors. With contributions by numerous experts. Series : Handbook of Experimental Pharmacology, Vol. 166. Gossen, Manfred; Kaufmann, Jörg; Triezenberg, Steven J. (Eds.). 2004. The present volume, authored by leading experts in the field, contains in-depth information regarding the role of transcription factors as key players in the execution of the genomic program of any given cell. Many of the chapters focus on the role of transcription factors in cellular transformation and cancer, other chapters highlight the contributions of transcription factors to inflammatory responses or xenobiotic responses. Moreover, the volume illustrates how a viral transcription factor interferes with the physiology of its host cell and finally points out how much exciting research transcription factor biology still has to offer. X, 581 p. 72 illus., Hardcover. ISBN: 3-540-21095-4. $399.00
Textbook of Receptor Pharmacology.
2nd edition.
John C Foreman & Torben
Johansen. 2002.
The bestselling first edition of Textbook of Receptor Pharmacology originated
from a renowned course in receptor pharmacology taught at the University College
of London for the past three decades. Its innovative format united four major
approaches to the study of receptors: molecular biology, quantitative functional
studies of agonists and antagonists, ligand binding, and signal transduction
systems. The second edition builds on this foundation. This edition streamlines
the material and focuses on cell membrane receptors along with their immediate
signal transducers. The section on the molecular structure of receptors reflects
the advances in this area. This edition also includes two restructured new
chapters, one on G-proteins and one on tyrosine kinases, as signal transductors.
Several chapters also contain problems for students to solve as well as
worked-out solutions. The book contains over one hundred useful diagrams and
tables to aid illustration of concepts and a helpful appendix explaining the
simple mathematics used in the text. A time-saving resource and comprehensive
textbook, Textbook of Receptor Pharmacology, Second Edition provides in-depth,
up-to-date coverage of this still rapidly expanding research area that is both
fundamental to the science of pharmacology and on the cutting edge of new drug
development. Key Features: Contains two new chapters: Molecular Structure of Tyrosine Kinase
Receptors and G-Proteins • Provides over a hundred diagrams and tables to aid illustration of
concepts, practice problems to facilitate comprehension, and an index
explaining the simple mathematics used in the text • Unites four major approaches in the study of receptors: molecular biology,
quantitative functional studies of agonists and antagonists, ligand binding,
and signal transduction systems • Includes an overview of the importance of receptors in drug development
written by Nobel Laureate James W. Black • Constructs a logical introduction to the various approaches that can be
taken to the study of drug receptors • Presents information from an international group of experts. 304 pp.
ISBN 0849310296 $99.95
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