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
Evaluation of Traditional Medicine.
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
Policy Issues for the New Millennium.
Science and Innovation Series.
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.
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
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:
- 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
- Professionals in Quality Assurance
- Training in Regulatory Affairs
ISBN 3-87193-324-4. hardcover. $608.00
Health Technical Memorandum 2010.
• 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).
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.
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
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,
Volume 5: Tests and General Requirements for Dosage Forms.
Quality Specifications for Pharmaceutical Substances and Dosage Forms.
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.
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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