The Textbook of Pharmaceutical Medicine, 5th Edition

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Format: eBook
Pub. Date: 2008-06-01
Publisher(s): BMJ Books
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Summary

New edition of succesful standard reference book for the pharmaceutical industry and pharmaceutical physicians!The Textbook of Pharmaceutical Medicine is the coursebook for the Diploma in Pharmaceutical Medicine, and is used as a standard reference throughout the pharmaceutical industry. The new edition includes greater coverage of good clinical practice, a completely revised statistics chapter, and more on safety. Covers the course information for the Diploma in Pharmaceutical Medicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe and regulation of therapeutic products in Australia

Table of Contents

Research and development
Discovery of new medicines
Pharmaceutical development
Preclinical safety testing
Exploratory development
Clinical pharmacokinetics
Purpose and design of clinical trials
Conduct of clinical trials: good clinical practice
Medical statistics
Development of medicines: full development
Medical department issues
The medical department
Medical marketing
Information and promotion
The supply of unlicensed medicines for particular patient use
Legal and ethical issues relating to medicinal products
The safety of medical products
Regulatory aspects
History of drug regulation in the United Kingdom
Regulation of human medicinal products in the European Union
European regulation of medical devices
Technical requirements for registration of pharmaceuticals for human use: the ICH process
The regulation of drug products by the United States Food and Drug Administration
The US FDA in the drug development, evaluation and approval process
Past evolution and future prospects of the Pharma Industry and its regulation in the USA
Regulatory and clinical trial systems in Japan
The regulation of therapeutic products in Australia
Pharmacoeconomic and other issues
Economics of healthcare
Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons
Declaration of Helsinki
Code of Practice for the Pharmaceutical Industry
Guidelines and Documentation for Implementation of Clinical Trials
Directive 2001/20/EC of the European Parliament and of the Council of 4 April
Index
Table of Contents provided by Publisher. All Rights Reserved.

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