Content:
Chapter 1 Discovery of New Medicines (pages 1?86): Anand S Dutta
Chapter 2 Pharmaceutical Development (pages 87?110): Gavin Halbert
Chapter 3 Preclinical Safety Testing (pages 111?143): David J Tweats
Chapter 4 Exploratory Development (pages 144?175): John Posner
Chapter 5 Clinical Pharmacokinetics (pages 176?197): Paul Rolan and Valeria Molnar
Chapter 6 Purpose and Design of Clinical Trials (pages 198?238): Roger A Yates
Chapter 7 Conduct of Clinical Trials: Good Clinical Practice (pages 239?274): Roger A Yates
Chapter 8 Medical Statistics (pages 275?309): Andrew P Grieve
Chapter 9 Development of Medicines: Full Development (pages 310?328): Alan G Davies and Peter D Stonier
Chapter 10 The Medical Department (pages 330?339): Darrall L Higson and PD Stonier
Chapter 11 Medical Marketing (pages 340?354): John H Young
Chapter 12 Information and Promotion (pages 355?379): D Michael Humphreys
Chapter 13 The Supply of Unlicensed Medicines for Particular Patient Use (pages 380?389): Amanda Wearing and John O’Grady
Chapter 14 Legal and Ethical Issues Relating to Medicinal Products (pages 390?409): Christine H Bendall and Christopher JS Hodges
Chapter 15 The Safety of Medical Products (pages 410?453): A Peter Fletcher and Susan Shaw
Chapter 16 History of Drug Regulation in the United Kingdom (pages 456?488): John P Griffin and Rashmi R Shah
Chapter 17 Regulation of Human Medicinal Products in the European Union (pages 489?534): Rashmi R Shah and John P Griffin
Chapter 18 European Regulation of Medical Devices (pages 535?551): Christopher JS Hodges
Chapter 19 Technical Requirements for Registration of Pharmaceuticals for Human Use: the ICH Process (pages 552?564): Dean WG Harron
Chapter 20 The Regulation of Drug Products by the United States Food and Drug Administration (pages 565?601): Peter Barton Hutt
Chapter 21 The US FDA in the Drug Development, Evaluation and Approval Process (pages 602?613): Richard N Spivey, Judith K Jones, William Wardell and William Vodra
Chapter 22 Past Evolution and Future Prospects of the Pharma Industry and its Regulation in the USA (pages 614?636): William Wardell, William Vodra, Judith K Jones and Richard N Spivey
Chapter 23 Regulatory and Clinical Trial Systems in Japan (pages 637?651): Yuichi Kubo
Chapter 24 The Regulation of Therapeutic Products in Australia (pages 652?684): Janice Hirshorn and Deborah Monk
Chapter 25 Economics of Healthcare (pages 686?701): Carole Bradley and Jane R Griffin
Chapter 26 Controls on NHS Medicines Prescribing and Expenditure in the UK (A Historical Perspective) with some International Comparisons (pages 702?719): John P Griffin and Jane R Griffin
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