内容

目次

Part I: Research and development. Introduction: the development of pharmaceutical medicine as a specialty ( Susan Bews and Huw Jones ). 1 Discovery of new medicines ( Anand S Dutta ). 2 Pharmaceutical development ( Gavin Halbert ). 3 Preclinical safety testing ( Lutz Mueller and David J Tweats ). 4 Exploratory development ( John Posner ). 5 Clinical pharmacokinetics ( Paul Rolan and Valeria Rolan ). 6 Purpose and design of clinical trials ( Roger A Yates and Steve Warrington ). 7 Conduct of clinical trials: good clinical practice ( Roger A Yates and Steve Warrington ). 8 Medical statistics ( Andrew P Grieve ). 9 Development of medicines: full development ( Alan G Davies and Peter D Stonier ). Part II: Medical department issues. 10 The medical department ( Peter D Stonier ). 11 Medical marketing ( David Galloway ). 12 Information and promotion ( Charles de W et). 13 The supply of unlicensed medicines for particular patient use ( Ian Dodds–Smith, Amanda Wearing and John O'Grady ). 14 Ethics of human experimentation ( Duncan Vere ). 15 Legal and ethical issues relating to medicinal products ( David Marks, Nick Beckett, Sarah Hanson and Shuna Mason ). 16 The safety of medical products ( A. Peter Fletcher and Susan Shaw ). Part III: Regulatory aspects. 17 History of drug regulation in the United Kingdom ( John P Griffin and Rashmi R Shah ). 18 Regulation of human medicinal products in the European Union ( John P Griffin and Rashmi R Shah ). 19 Paediatric regulation ( Heike Rabe ). 20 European regulation of medical devices ( Christopher JS Hodges ). 21 Technical requirements for registration of pharmaceuticals for human use: the ICH process ( Dean W G Harron ). 22 The regulation of drug products by the United States Food and Drug Administration ( Peter Barton Hutt ). 23 The US FDA in the drug development, evaluation and approval process ( Richard N Spivey, Judith K Jones, William Wardell and William Vodra ). 24 Past evolution and future prospects of the Pharma Industry and its regulation in the USA ( William Wardell, William Vodra, Judith K Jones and Richard N Spivey ). 25 Regulatory and clinical trial systems in Japan ( Yuichi Kubo ). 26 The regulation of therapeutic products in Australia ( Janice Hirshorn and Deborah Monk ). 27 Pharmaceutical medicine in emerging markets ( N. Shreeharan ). Part IV: Pharmacoeconomic and other issues. 28 Economics of healthcare ( Carole Bradley–Kennedy and Jane R Griffin ). 29 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons ( John P Griffin and Jane R Griffin ). 30 Due diligence and the pharmaceutical physician ( Geoff Barker ). Appendix 1 Declaration of Helsinki. Appendix 2 Code of Practice for the Pharmaceutical Industry. Appendix 3 Guidelines and Documentation for Implementation of Clinical Trials. Appendix 4 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001.