The Textbook of Pharmaceutical Medicine, 6th Edition

The Textbook of Pharmaceutical Medicine is a standard reference for all those working in pharmaceutical medicine and the recognised text for the UK Faculty of Pharmaceutical Medicine Diploma. This is a comprehensive volume covering the processes by which medicines are developed, tested and approved. Regulations for drug development in the UK, EU, USA, Australia and Japan are discussed, providing relevant information for drug approval in the main continents where new drugs are developed. The chapters are written by leading academics, medical directors and lawyers, providing authoritative and in-depth information for trainees on the Faculty course, and for physicians working in the pharmaceutical industry. As well as thorough updating of the regulatory chapters, the 6th edition includes chapters on these vital new areas: Paediatric regulationEthicsDue diligence and the pharmaceutical physicianContent: Chapter 1 Discovery of New Medicines (pages 1–80): Anand S. DuttaChapter 2 Pharmaceutical Development (pages 81–100): Gavin HalbertChapter 3 Preclinical Safety Testing (pages 101–136): Lutz Muller and Anke LuheChapter 4 Exploratory Development (pages 137–166): John PosnerChapter 5 Clinical Pharmacokinetics (pages 167–184): Paul Rolan and Valeria MolnarChapter 6 Purpose and Design of Clinical Trials (pages 185–206): Steve WarringtonChapter 7 Conduct of Clinical Trials: Good Clinical Practice (pages 207–239): Kate L. R. DarwinChapter 8 Medical Statistics (pages 240–269): Andrew P. GrieveChapter 9 Development of Medicines: Full Development (pages 270–284): Peter D. StonierChapter 10 The Medical Department (pages 285–295): Peter Stonier and David GillenChapter 11 Medical Marketing (pages 296–309): David Galloway and Bensita BernardChapter 12 Information and Promotion (pages 310–330): Charles de WetChapter 13 The Supply of Unlicensed Medicines for Individual Patient use (pages 331–346): Ian Dodds?Smith and Silvia ValverdeChapter 14 Human Experimentation – Ethics of First Human Exposure (pages 347–350): Duncan W. VereChapter 15 Legal and Ethical Issues Relating to Medicinal Products (pages 351–371): Nick Beckett, Sarah Hanson, Christopher J. S. Hodges and Shuna MasonChapter 16 The Safety of Medical Products (pages 372–409): A. Peter Fletcher and Susan ShawChapter 17 History of Drug Regulation in the UK (pages 411–443): John P. GriffinChapter 18 Regulation of Human Medicinal Products in the European Union (pages 444–499): Rashmi R. Shah and Agnes Saint RaymondChapter 19 Paediatric Regulation (pages 500–506): Heike RabeChapter 20 European Regulation of Medical Devices (pages 507–521): Christopher J. S. HodgesChapter 21 Technical Requirements for Registration of Pharmaceuticals for Human use: the ICH Process (pages 522–533): Dean W. G. HarronChapter 22 The Regulation of Drug Products by the US Food and Drug Administration (pages 534–566): Peter Barton HuttChapter 23 The US FDA in the Drug Development, Evaluation and Approval Process (pages 567–584): Richard N. Spivey, Judith K. Jones, William Wardell and William VodraChapter 24 Future Prospects of the Pharmaceutical Industry and its Regulation in the USA (pages 585–601): William Wardell, Judith K. Jones, Richard N. Spivey and William VodraChapter 25 Regulatory and Clinical Trial Systems in Japan (pages 602–612): Yuichi KuboChapter 26 The Regulation of Therapeutic Products in Australia (pages 613–640): Janice Hirshorn and Deborah MonkChapter 27 Pharmaceutical Medicine in the Emerging Markets (pages 641–657): Nadarajah Sreeharan and Jennie A. SykesChapter 28 Economics of Health Care (pages 661–673): Carole A. Bradley and Jane R. GriffinChapter 29 Controls on NHS Medicines Prescribing and Expenditure in the UK (a Historical Perspective) with some International Comparisons (pages 674–690): John P. Griffin and Jane R. GriffinChapter 30 Due Diligence and the Role of the Pharmaceutical Physician (pages 691–699): Geoffrey R. Barker

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