Fiedler
- Encyclopedia of Excipients. Hoepfner, Eva-Marie; Lang, Siegfried; Reng,
Alwin; Schmidt, Peter Christian. due March-April. 2007. 6th ed. More
than 12,900 new and revised excipients arranged according to pharmacopoeia
title, INCI, INN, CAS, chemical name and synonyms, formula, etc,
preparation, properties, product data, applications, toxicology (with an
actual overview of pharmacological and toxicological properties and allergy-induing
reactions and FDA status), analytics, references (reviews up to 2005),
single products of groups of substances. Encyclopedic entries give a base
and overview with general descriptions of raw materials (e.g. Butane,
lactose), of substance classes (e.g. eye preparations, moisturizers,
plasticizers, tablet excipients), abbreviations of important names and
institutions (EINECS). Also has a completely revised manufacturers list with
more than 400 firms and websites and current products. A new and revised
survey tables for international use with a separate sections for cosmetic
ingredients review (CIR), coloring agents for cosmetics and drugs, dangerous
substances, food additives, preservatives, sieves, solubilizers,
surfactants, etc. 1600 pp. hardcover. 2 volumes. ISBN:
3-87193-346-5. $560.00; CDROM version: ISBN 3-87193-347-3. $560.00; print+
cdrom 3-87193-345-7 $800.00
Future Strategies for Drug Delivery with Particulate Systems.
Edited by Julia E. Diederichs & Rainer H. Müller. 1998.
Research
on particulate delivery systems is an important discipline of the pharmaceutical
sciences, being performed in many academic and industrial laboratories all
around the world. Particulate systems offer a large potential for the controlled
delivery of drugs, diagnostic agents, antigens, and genetic material.
Additionally they are of increasing interest for the controlled delivery of
active compounds in cosmetics. The book presents trends and future strategies in
these fields using: liposomes • emulsions • polymeric nanoparticles • solid lipid nanoparticles (SLNTM, LipopearlsTM)
• nanosuspensions of poorly soluble & bioavailable drugs • particulate diagnostics. In this book, European pharmaceutical research groups at the universities of
Berlin, Copenhagen, Paris and Utrecht present their current research activities
and outline the strategies for controlled delivery of the future. Contents: Nanoparticles and Liposomes for Drug Targeting • Liquid Based Drug Delivery
Systems for Peptide and Protein Drug Delivery • Interaction of Plasma Proteins
with Liposomes • Influence of Surface Properties on Adsorption Patterns and
Protein Conformation • Iron Oxides as Contrast Agents in Magnetic Resonance Lymphography
• Solid Liquid Nanoparticles, Nanosuspensions and Liposomes for
Pharmaceutical Cosmetic Applications • Liposomes as Drug Carrier for
Diagnostics, Cytostatics and Genetic Material • Strategies for Site Specific,
Time and Rate Controlled Delivery of Drugs, Genes and Antigenes • Index.
Softcover, 194 pp., 68 figs., 12 tables.
ISBN 3 88763 061 0
$64.00
GCP Auditing. Methods and Experiences. Presented by an Expert Group of the German Society for Good Research Practice,. 2nd revised edition. 2007. Due to the ”Good Clinical Practice” (GCP) requirements the high demands of quality assurance internationally became an integral part in the conduct of clinical trials. The conducting of audits enables pharmaceutical companies, CROs, authorities etc. to verify whether the required standards are complied with. The methods used for the planning, conducting and evaluation of auditing measures are presented in detail. Thus this textbook provides the necessary material for both the audits as such and for their evaluation. Different fields of work are presented – investigator, clinic, laboratory and CROs. The subjects dealt with include the trial protocol, information for study participants, computer system validation, validation in clinical studies employing electronic data capture systems, audit schedule and audit report. The authors (members of a board of experts of the Deutsche Gesellschaft für Gute Forschungspraxis, DGGF; German Society for Good Research Practice) work in the pharmaceutical industry or at CROs and have had many years of experience in the quality assurance field. 192 pp. ISBN 10: 3-87193-356-2; ISBN 13: 978-3-87193-356-1. $110.00
General Guidelines for Methodologies on
Research and
Evaluation of Traditional Medicine.
WHO. 2002.
These general guidelines have been developed to consider the types of
academic research methods used to evaluate the safety and efficacy of
traditional medicine. They aim to harmonize the use of certain accepted and
important terms, and provide appropriate evaluation methods to aid the
development of regulation and registration mechanisms. The guidelines contain
sections on: herbal medicines, traditional procedure-based therapies, clinical
research, and related issues including ethics, education and training, and
surveillance systems. Paperback. vi + 71 pp.
ISBN 0119869357 $24.00
Genetic Testing.
Policy Issues for the
New Millennium.
Science and Innovation Series.
OECD. 2001.
Genetic tests are being developed at an impressive rate and a significant number have already reached the market. Substantial involvement of the private sector has led to unprecedented growth in commercial genetic testing services and in trade of such services. This trend is expected to increase as knowledge gained from the mapping of the human genome and of single nucleotide polymorphisms
(SNPs) is applied to the identification of disease-causing genes and of inherited differences in drug response. The potential socio-economic and ethical impacts are staggering. This report provides a state-of-the-art review of advances in genetic testing and of main international policy concerns drawing from the OECD workshop on “Genetic Testing: Policy Issues for the New Millennium” held in Vienna on 23-25 February 2000.
Paperback, 76 pp.
ISBN 9264183043 $24.00
Good Manufacturing Practice (GMP)
Guidelines for Radiopharmaceutical Products.
WHO. 2001.
These guidelines are included in the publication
WHO Expert Committee on Specifications for Pharmaceutical Preparations 37th
Report, English 2003 Technical Report Series, No. 908. 144 pp.
ISBN 9241209089 $34.00
Guide to the Preparation, Use and Quality Assurance of Blood
Components. 9th
Edition.
Council
of Europe. 2002.
In
the absence of substitutes, the use of blood components remains essential in
therapy. This new edition presents a compendium of measures designed to ensure
the safety, efficacy and quality of blood components and is particularly
intended for all those working in blood transfusion services. In
accordance with the approach recommended by the Council of Europe, the guide is
based on the premise of voluntary, non-remunerated blood donation. It also
describes the different blood components and gives information on their clinical
indications and possible side effects. Adopted
in 1995 as a technical appendix to Recommendation no. R (95) 15 of the Council
of Europe, this guide continues to be the 'Golden Standard' for blood
transfusion services and forms the basis for many national guidelines, in Europe
and outside. For example, in 2000 Australia mandated the guide in its standard
for blood components. In
this 8th edition, chapter 12 on red cells obtained by aphaeresis has been
completely overhauled. Where necessary, chapters have been revised in order to
take into account what can be achieved with new technology. For example, in
chapter 1 on selection of donors the requirements for aphaeresis donors have been
updated. The
Guide to the Preparation, Use and Quality Assurance of Blood Components
will be of interest to blood transfusion centers, legislators, health personnel
and all those working in the field of blood transfusion. Paperback, 267 pp.
ISBN 9287150753
$34.00
Guide to Drug Regulatory Affairs. B. Friese, B. Jentges, U. Muazzam und Beiträgen von T.
A. Keller, C. Oldenhof, K. Olejniczak, H. Potthast, Joachim A. Schwarz,
B. Sickmueller. 2007.
This is the first comprehensive overview of the legal and
regulatory
framework for marketing authorisation applications in Europe,
including
Switzerland. It gives extensive and valuable advice on how to compile
a marketing authorisation according to the CTD format (Modules 1 – 5
CTD).
The ’Guide’ has been developed to penetrate the ’regulatory jungle’
and make related work much easier and more efficient. With both a
printed and a regularly updated online edition, the ‘Guide’ is a
multi-media platform designed to support the different needs of its
many users.
The ’Guide’ is subdivided into four major parts
Contents – The print edition with more than 800 pages is primarily intended as an invaluable reference-book.
The key benefits of the constantly updated, user friendly and easily navigated online edition include:
Target groups:
- Employees, Executives and Directors of Pharmaceutical Companies
and the
API Industry (API Active Pharmaceutical Ingredients)
- Legal Advisers and Attorneys
- Employees and Heads of Regulatory Authorities
- Consultants
- Professionals in Quality Assurance
- Training in Regulatory Affairs
ISBN 3-87193-324-4. hardcover. $608.00
Health Technical Memorandum 2010.
NHS Estates.
Available volumes:
• Sterilization. Parts 4 and 6. 1997.
Part 4: Operational management (new
edition) with Part 6: Testing and validation protocols. 242 pp.
ISBN 0 11 322031 6 $216.00
•
Fluids sterilizer log book.
In accordance with Health technical memorandum 2010 & with reference to B.S.
3970 parts 1 & 2. 2000. Shrink wrapped, ring binder, 325 pp.
ISBN 0 11 322397 8 $117.00
• Unwrapped instrument & utensil sterilizer log book.
2000. Shrink wrapped, ring binder, 150 pp.
ISBN 0 11 322400 1 $80.00
Index Nominum 2000.
International Drug Directory. 17th edition
Swiss Pharmaceutical Society. 2000.
Supercedes the 16th revised edition. xviii, 1932 pp., ill.: 31 cm.
ISBN 3 88763 075 0 $286.00
International Classification of Diseases for Oncology. (ICD-O).
3rd Edition.
WHO. 2001.
Now in its third edition, the
International Classification of Diseases for Oncology (ICD-O) has been used for
nearly 25 years as the standard tool for coding diagnoses of neoplasms in tumor
and cancer registrars and in pathology laboratories. ICD-O is a dual
classification with coding systems for both topography and morphology. The
topography code describes the site of origin of the neoplasm and uses the same
3-character and 4-character categories as in the neoplasm section of Chapter II,
ICD-10. The morphology code describes the characteristics of the tumor itself,
including its cell type and biologic activity.
The book has five main sections. 1. general instructions for using the coding systems and rules for their
implementation in tumor registries and pathology laboratories;
2. numerical list of topography codes - unchanged from the previous edition;
3. numerical list of morphology codes - introduces several new terms;
4. alphabetical index - gives codes for both topography and morphology and
includes selected tumor-like lesions and conditions;
5. guide to differences in morphology codes between the second and third
editions- includes lists of all new code numbers, new terms and synonyms added
to existing code definitions, terms that changed morphology code, terms for
conditions now considered malignant, deleted terms, and terms that changed
behavior code. In preparing this new edition, the editors have made a special effort to
change as few terms as possible, to add new terms at empty spaces, and to
avoid reuse of previously assigned codes. To the greatest extent possible, ICD-O uses the nomenclature published in
the WHO series, International Histological Classification of Tumours.
Hardcover, vii + 240 pp.
ISBN 9241545348 $76.00
International Directory of eHealth and Telemedicine 2000/2001.
2000.
The extraordinary developments that are occurring in such fields as
computing, communications and medical technologies are now making possible
long-foreseen advances in telemedicine and telecare. The Yearbook is a
comprehensive database of the telemedicine suppliers and providers worldwide. An
essential reference for everyone in the healthcare industry. The growing importance of telemedicine both within the NHS and the private
sector has been stressed by all concerned in the delivery of healthcare - at
government level, by the WHO and the EU. Key Features: Written in collaboration with the TeleMedicine UK
• Nothing similar yet
exists • Promotes the development of telemedicine policy and standards, encouraging
the adoption of uniform standards and practice • Ensures the recognition by the authorities of the need to protect the
intellectual property rights developed in the industry • Interacting with telemedicine associations in other countries.
Hardcover + CD-ROM, 400 pp.
ISBN 0117024740 $248.00
International Nonproprietary Names (INN) for Pharmaceutical Substances
CD-ROM.
Lists
1-45 of Proposed INN and List 1-85 of Recommended INN Cumulative List No. 10.
WHO. 2002. Published by The Stationery Office.
All INNs published in the lists
1-45 of proposed and 1-85 of recommended INNs are now also available in
electronic form on CD-ROM. Also included on the CD-ROM are the following
documents: Guidelines on the Use of INNS, The Use of Common Stems in the
Selection of INNs and Names of Radicals and Groups.
CD-ROM: ISBN 924056019X $333.00
The International Pharmacopoeia,
3rd Edition.
Volume 5: Tests and General Requirements for Dosage Forms.
Quality Specifications for Pharmaceutical Substances and Dosage Forms.
WHO. 2003.
This volume of the International Pharmacopoeia
practically completes the list of monographs for active pharmaceutical
substances. It describes methods and procedures for the quality control of
pharmaceutical substances and dosage forms, and details amendments to volumes
1-4. It includes a large number of monographs for tablets, the most applicable
dosage form used in health care, as well as a special section on newly developed
anti-malarial drug substances and their most widely used dosage forms. Volume 5
provides key information for companies seeking test methodologies not always
covered by the US or British Pharmacopoeias. Paperback, 371 pp.
ISBN 9241545364 $94.00
International Statistical Classification of Diseases and Related Health Problems (ICD-10) CD-ROM.
Lists 1-45 of Proposed INN and List 1-84 of Recommended INN Cumulative List No. 10.
WHO. 2003.
The ICD has become the standard international
diagnostic classification, used for both epidemiological and health management
purposes. Now for the first time the 12,420 codes of the ICD-10 are available from WHO on CD-ROM. The full text of the printed volumes is included, hyperlinks simplify navigation within the classification, and all terms and codes are indexed for easy searching. The ICD-10 codes are ready for uploading into database systems.
Key Features: To help users familiar with the printed version of the ICD-10, the CD-ROM has a similar layout. The full text of each volume is presented in its familiar multilevel structure
• A list of the volume’s contents appears in a side-window that can be re-sized according to the user’s needs
• All terms and codes are indexed to make searching easy • Using roll-down menus, the context-sensitive online help facility gives full explanations of all procedures
• Internal hypertext links help the user to navigate through the classification. CD-ROM.
ISBN 9241545402 $243.00
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