Hjem

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 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. Griffin 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