The Textbook of Pharmaceutical Medicine 7e

John Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM; Director, Asklepieion Consultancy Ltd; Visiting Professor, University of Surrey Postgraduate Medical School; Former Director, ABPI; Formerly Professional Head of the Medicines Division, DHSS, London. John Posner BSc PhD MBBS FRCP FFPM; Independent Consultant in Pharmaceutical Medicine, John Posner Consulting, Beckenham, Kent, UK; Chairman of the Board of Examiners of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians (UK). Geoffrey R. Barker TD, BSc, MSc, FDSRCD, FRCS, FFPM; Adj. Professor Immunology, Duke University Medical Center, NC, USA; Executive and Limited Partner, Pappas Ventures, NC, USA; Consultant to EGeen (USA), Abingworth LLP (UK), Reuters; Insight Community of Experts; Trustee Member of the Board of the Faculty of Pharmaceutical Physicians of The Royal Colleges of Physicians UK.

Contributors vii The editors x Acknowledgements xiii List of abbreviations xiv Preface xix 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 Muller and Elisabeth Husar 4 Exploratory development 82 John Posner 5 Clinical pharmacokinetics 113 Paul Rolan and Valeria Molnar 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 Agnes Saint Raymond 19 Human medicinal products in the European Union: Regulations Directives and structures 360 Agnes Saint Raymond and Anthony J. Humphreys 20 Human medicinal products in the European Union: Procedures 379 Agnes Saint Raymond and Anthony J. Humphreys 21 European regulation of medical devices 418 Shuna Mason 22 Paediatric regulation 435 Heike Rabe and Agnes 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 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