Textbook of Pharmaceutical Medicine

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 viiThe editors xAcknowledgements xiiiList of abbreviations xivPreface xixPart I Research and development 11 Discovery of new medicines 3Yves J. Ribeill2 Pharmaceutical development 32Michael Gamlen and Paul Cummings3 Preclinical safety testing 42Lutz Müller and Elisabeth Husar4 Exploratory development 82John Posner5 Clinical pharmacokinetics 113Paul Rolan and Valéria Molnár6 Biological therapeutics 132Peter Lloyd and Jennifer Sims7 Objectives and design of clinical trials 143John Posner and Steve Warrington8 Conduct of clinical trials: Good Clinical Practice 155Kate L.R. Darwin9 Medical statistics 189Andrew P. Grieve10 Development of medicines: full development 219Peter D. Stonier11 Pharmacovigilance 235Stephen F. Hobbiger, Bina Patel and Elizabeth Swain12 Vaccines 254John Beadle13 Drugs for cancer 270James Spicer and Johann De Bono14 Ethics of human experimentation 286Jane Barrett15 Drug development in paediatrics and neonatology 295Nazakat M. Merchant and Denis V. Azzopardi16 Due diligence and the role of the pharmaceutical physician 306Geoffrey R. BarkerPart II Regulation 31717 A history of drug regulation in the UK 319John P. Griffin18 The Clinical Trials Directive 347Fergus Sweeney and Agnès Saint Raymond19 Human medicinal products in the European Union: Regulations Directives and structures 360Agnès Saint Raymond and Anthony J. Humphreys20 Human medicinal products in the European Union: Procedures 379Agnès Saint Raymond and Anthony J. Humphreys21 European regulation of medical devices 418Shuna Mason22 Paediatric regulation 435Heike Rabe and Agnès Saint-Raymond23 Technical requirements for registration of pharmaceuticals for human use: The ICH process 447Dean W.G. Harron24 The regulation of drug products by the US Food and Drug Administration 461Peter Barton Hutt25 The US FDA in the drug development evaluation and approval process 501Richard N. Spivey, Judith K. Jones, William Wardell and William W. Vodra26 Future prospects of the pharmaceutical industry and its regulation in the USA 518Richard N. Spivey, William W. Vodra, Judith K. Jones and William Wardell27 Regulatory and clinical trial systems in Japan 537Mamiko Satake and Natsuko Hosoda28 The regulation of therapeutic products in Australia 554Elizabeth de Somer, Deborah Monk and Janice HirshornPart III Health care marketplace 58729 An Introduction to life cycle management of medicines 589David Gillen30 Availability of medicines online and counterfeit medicines 597Ruth Diazaraque and David Gillen31 The supply of unlicensed medicines for individual patient use 610Ian Dodds-Smith and Ewan Townsend32 Legal and ethical issues relating to medicinal products 632Nick Beckett, Sarah Hanson and Shuna Mason33 Medical marketing 653David B. Galloway and Bensita M.V. Thottakam34 Information and promotion 670Charles De Wet35 Economics of health care 692Carole A. Bradley and Jane R. Griffin36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons 707John P. Griffin and Geoffrey R. Barker37 Pharmaceutical medicine in the emerging markets 728Nadarajah Sreeharan, Jennie A. Sykes and Richard B. Nieman38 Biosimilars 744Raymond A. Huml and John PosnerAppendix 1 Declaration of Helsinki 751Appendix 2 Agreements and Guidelines for Implementation of Clinical Trials 755Appendix 3 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 771Appendix 4 PharmaTrain Syllabus 2010 783Index 788

“This comprehensive volume covers the processes by which medicines are developed, tested and approved. The chapters are written by leading academics, medical directors and legal experts in the field of harmaceutical medicine and provide authorative and in-depth information for both physicians working in and those who are currently training in the pharmaceutical industry.”  (British Journal of Clinical Pharmacology, 22 April 2014)“This book is expected to be useful for pharmaceutical physicians and for anyone interested in learning about the various issues in drug discovery and development. In addition to many other topics, the regulatory aspects of drug development in the U.S., Europe, and Japan are well covered . . . Nevertheless, this is an admirable effort and the book deserves a place on the bookshelves of pharmaceutical physicians. ”  (Doody’s, 30 August 2013)