Griffin John P (ed.) The Textbook of Pharmaceutical Medicine

6th edition. — Wiley-Blackwell, BMJ Books, 2009. — 776 p.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.Research and development:
Introduction: the development of pharmaceutical medicine as a specialty
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
Ethics of human experimentation
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
Paediatric regulation
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
Pharmaceutical medicine in emerging markets
Pharmacoeconomic and other issues:
Economics of healthcare
Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons
Due diligence and the pharmaceutical physician