The Textbook of Pharmaceutical Medicine

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.
There are also new chapters on biotechnology and pharmaceutical medicine in
developing countries.

Table of Contents

Part I: Research and development 1 Discovery of new medicines Anand S Dutta 2
Pharmaceutical development Gavin Halbert 3 Preclinical safety testing David J
Tweats 4 Exploratory development John Posner 5 Clinical pharmacokinetics Paul
Rolan and Valeria Molnar 6 Purpose and design of clinical trials Roger A Yates
7 Conduct of clinical trials: good clinical practice Roger A Yates 8 Medical
statistics Andrew P Grieve 9 Development of medicines: full development Alan G
Davies and Peter D Stonier
Part II: Medical department issues 10 The medical department Darrall L Higson
(with revisions by Peter D Stonier) 11 Medical marketing John H Young 12
Information and promotion D Michael Humphreys 13 The supply of unlicensed
medicines for particular patient use Amanda Wearing and John O' Grady 14 Legal
and ethical issues relating to medicinal products Christine H Bendall and
Christopher JS Hodges 15 The safety of medical products A Peter Fletcher and
Susan Shaw
Part III: Regulatory aspects 16 History of drug regulation in the United
Kingdom John P Griffin and Rashmi R Shah 17 Regulation of human medicinal
products in the European Union Rashmi R Shah and John P Griffin 18 European
regulation of medical devices Christopher JS Hodges 19 Technical requirements
for registration of pharmaceuticals for human use: the ICH process Dean W G
Harron 20 The regulation of drug products by the United States Food and Drug
Administration Peter Barton Hutt 21 The US FDA in the drug development,
evaluation and approval process Richard N Spivey, Judith K Jones, WilliamW
ardell and WilliamV odra 22 Past evolution and future prospects of the Pharma
Industry and its regulation in the USA WilliamW ardell, WilliamV odra, Judith K
Jones and Richard N Spivey 23 Regulatory and clinical trial systems in Japan
Yuichi Kubo 24 The regulation of therapeutic products in Australia Janice
Hirshorn and Deborah Monk
Part IV: Pharmacoeconomic and other issues 25 Economics of healthcare Carole
Bradley and Jane R Griffin 26 Controls on NHS medicines prescribing and
expenditure in the UK (a historical perspective) with some international
comparisons John P Griffin and Jane R Griffin Appendix 1: Declaration of
Helsinki Appendix 2: Code of Practice for the Pharmaceutical Industry Appendix
3: Guidelines and Documentation for Implementation of Clinical Trials Appendix
4: Directive 2001/20/EC of the European Parliament and of the Council of 4
April 2001 Index