Table of Contents
Contributors vii
The editors x
Acknowledgements xiii
List of abbreviations xiv
Preface xix
Part I Research and development 1
1 Discovery of new medicines 3Yves J. Ribeill
2 Pharmaceutical development 32Michael Gamlen and Paul Cummings
3 Preclinical safety testing 42Lutz Müller and Elisabeth Husar
4 Exploratory development 82John Posner
5 Clinical pharmacokinetics 113Paul Rolan and Valéria Molnár
6 Biological therapeutics 132Peter Lloyd and Jennifer Sims
7 Objectives and design of clinical trials 143John Posner and Steve Warrington
8 Conduct of clinical trials: Good Clinical Practice 155Kate L.R. Darwin
9 Medical statistics 189Andrew P. Grieve
10 Development of medicines: full development 219Peter D. Stonier
11 Pharmacovigilance 235Stephen F. Hobbiger, Bina Patel and Elizabeth Swain
12 Vaccines 254John Beadle
13 Drugs for cancer 270James Spicer and Johann De Bono
14 Ethics of human experimentation 286Jane Barrett
15 Drug development in paediatrics and neonatology 295Nazakat M. Merchant and Denis V. Azzopardi
16 Due diligence and the role of the pharmaceutical physician 306Geoffrey R. Barker
Part II Regulation 317
17 A history of drug regulation in the UK 319John P. Griffin
18 The Clinical Trials Directive 347Fergus Sweeney and Agnès Saint Raymond
19 Human medicinal products in the European Union: Regulations Directives and structures 360Agnès Saint Raymond and Anthony J. Humphreys
20 Human medicinal products in the European Union: Procedures 379Agnès Saint Raymond and Anthony J. Humphreys
21 European regulation of medical devices 418Shuna Mason
22 Paediatric regulation 435Heike Rabe and Agnès Saint-Raymond
23 Technical requirements for registration of pharmaceuticals for human use: The ICH process 447Dean W.G. Harron
24 The regulation of drug products by the US Food and Drug Administration 461Peter Barton Hutt
25 The US FDA in the drug development evaluation and approval process 501Richard N. Spivey, Judith K. Jones, William Wardell and William W. Vodra
26 Future prospects of the pharmaceutical industry and its regulation in the USA 518Richard N. Spivey, William W. Vodra, Judith K. Jones and William Wardell
27 Regulatory and clinical trial systems in Japan 537Mamiko Satake and Natsuko Hosoda
28 The regulation of therapeutic products in Australia 554Elizabeth de Somer, Deborah Monk and Janice Hirshorn
Part III Health care marketplace 587
29 An Introduction to life cycle management of medicines 589David Gillen
30 Availability of medicines online and counterfeit medicines 597Ruth Diazaraque and David Gillen
31 The supply of unlicensed medicines for individual patient use 610Ian Dodds-Smith and Ewan Townsend
32 Legal and ethical issues relating to medicinal products 632Nick Beckett, Sarah Hanson and Shuna Mason
33 Medical marketing 653David B. Galloway and Bensita M.V. Thottakam
34 Information and promotion 670Charles De Wet
35 Economics of health care 692Carole A. Bradley and Jane R. Griffin
36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons 707John P. Griffin and Geoffrey R. Barker
37 Pharmaceutical medicine in the emerging markets 728Nadarajah Sreeharan, Jennie A. Sykes and Richard B. Nieman
38 Biosimilars 744Raymond A. Huml and John Posner
Appendix 1 Declaration of Helsinki 751
Appendix 2 Agreements and Guidelines for Implementation of Clinical Trials 755
Appendix 3 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 771
Appendix 4 PharmaTrain Syllabus 2010 783
Index 788
