Part I Research and development 1
1 Discovery of new medicines 3
Yves J. Ribeill
2 Pharmaceutical development 32
Michael Gamlen and Paul Cummings
3 Preclinical safety testing 42
Lutz Müller and Elisabeth Husar
4 Exploratory development 82
John Posner
5 Clinical pharmacokinetics 113
Paul Rolan and Valéria Molnár
6 Biological therapeutics 132
Peter Lloyd and Jennifer Sims
7 Objectives and design of clinical trials 143
John Posner and Steve Warrington
8 Conduct of clinical trials: Good Clinical Practice 155
Kate L.R. Darwin
9 Medical statistics 189
Andrew P. Grieve
10 Development of medicines: full development 219
Peter D. Stonier
11 Pharmacovigilance 235
Stephen F. Hobbiger Bina Patel and Elizabeth Swain
12 Vaccines 254
John Beadle
13 Drugs for cancer 270
James Spicer and Johann De Bono
14 Ethics of human experimentation 286
Jane Barrett
15 Drug development in paediatrics and neonatology 295
Nazakat M. Merchant and Denis V. Azzopardi
16 Due diligence and the role of the pharmaceutical physician 306
Geoffrey R. Barker

Part II Regulation 317
17 A history of drug regulation in the UK 319
John P. Griffin
18 The Clinical Trials Directive 347
Fergus Sweeney and Agnès Saint Raymond
19 Human medicinal products in the European Union: Regulations Directives and structures 360
Agnès Saint Raymond and Anthony J. Humphreys
20 Human medicinal products in the European Union: Procedures 379
Agnès Saint Raymond and Anthony J. Humphreys
21 European regulation of medical devices 418
Shuna Mason
22 Paediatric regulation 435
Heike Rabe and Agnès Saint-Raymond
23 Technical requirements for registration of pharmaceuticals for human use: The ICH process 447
Dean W.G. Harron
24 The regulation of drug products by the US Food and Drug Administration 461
Peter Barton Hutt
25 The US FDA in the drug development evaluation and approval process 501
Richard N. Spivey Judith K. Jones William Wardell and William W. Vodra
26 Future prospects of the pharmaceutical industry and its regulation in the USA 518
Richard N. Spivey William W. Vodra Judith K. Jones and William Wardell
27 Regulatory and clinical trial systems in Japan 537
Mamiko Satake and Natsuko Hosoda
28 The regulation of therapeutic products in Australia 554
Elizabeth de Somer Deborah Monk and Janice Hirshorn

Part III Health care marketplace 587
29 An Introduction to life cycle management of medicines 589
David Gillen
30 Availability of medicines online and counterfeit medicines 597
Ruth Diazaraque and David Gillen
31 The supply of unlicensed medicines for individual patient use 610
Ian Dodds-Smith and Ewan Townsend
32 Legal and ethical issues relating to medicinal products 632
Nick Beckett Sarah Hanson and Shuna Mason
33 Medical marketing 653
David B. Galloway and Bensita M.V. Thottakam
34 Information and promotion 670
Charles De Wet
35 Economics of health care 692
Carole A. Bradley and Jane R. Griffin
36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons 707
John P. Griffi n and Geoffrey R. Barker
37 Pharmaceutical medicine in the emerging markets 728
Nadarajah Sreeharan Jennie A. Sykes and Richard B. Nieman
38 Biosimilars 744
Raymond A. Huml and John Posner
Appendix 1 Declaration of Helsinki 751
Appendix 2 Agreements and Guidelines for Implementation of Clinical Trials 75
Appendix 3 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 771
Appendix 4 PharmaTrain Syllabus 783
Index 788