The Textbook of Pharmaceutical Medicine

The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine. This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine. Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine. The text breaks down into three core sections: Part I: Research and Development Part II: Regulation Part III: Healthcare marketplace View Table of Contents in detail INDICE: Contributors The editors Acknowledgements List of abbreviations Preface Part I Research and development 1 Discovery of new medicines Yves J. Ribeill 2 Pharmaceutical development Michael Gamlen and Paul Cummings 3 Preclinical safety testing Lutz Müller and Elisabeth Husar 4 Exploratory development John Posner 5 Clinical pharmacokinetics Paul Rolan and Valéria Molnár 6 Biological therapeutics Peter Lloyd and Jennifer Sims 7 Objectives and design of clinical trials John Posner and Steve Warrington 8 Conduct of clinical trials: Good Clinical Practice Kate L.R. Darwin 9 Medical statistics Andrew P. Grieve 10 Development of medicines: full development Peter D. Stonier 11 Pharmacovigilance Stephen F. Hobbiger, Bina Patel and Elizabeth Swain 12 Vaccines John Beadle 13 Drugs for cancer James Spicer and Johann De Bono 14 Ethics of human experimentation Jane Barrett 15 Drug development in paediatrics and neonatology Nazakat M. Merchant and Denis V. Azzopardi 16 Due diligence and the role of the pharmaceutical physician Geoffrey R. Barker Part II Regulation 17 A history of drug regulation in the UK John P. Griffin 18 The Clinical Trials Directive Fergus Sweeney and Agnès Saint Raymond 19 Human medicinal products in the European Union: Regulations, Directives and structures Agnès Saint Raymond and Anthony J. Humphreys 20 Human medicinal products in the European Union: Procedures Agnès Saint Raymond and Anthony J. Humphreys 21 European regulation of medical devices Shuna Mason 22 Paediatric regulation Heike Rabe and Agnès Saint–Raymond 23 Technical requirements for registration of pharmaceuticals for human use: The ICH process Dean W.G. Harron 24 The regulation of drug products by the US Food and Drug Administration Peter Barton Hutt 25 The US FDA in the drug development, evaluation and approval process 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 Richard N. Spivey, William W. Vodra, Judith K. Jones and William Wardell 27 Regulatory and clinical trial systems in Japan Mamiko Satake and Natsuko Hosoda 28 The regulation of therapeutic products in Australia Elizabeth de Somer, Deborah Monk and Janice Hirshorn Part III Health care marketplace 29 An Introduction to life cycle management of medicines David Gillen 30 Availability of medicines online and counterfeit medicines Ruth Diazaraque and David Gillen 31 The supply of unlicensed medicines for individual patient use Ian Dodds–Smith and Ewan Townsend 32 Legal and ethical issues relating to medicinal products Nick Beckett, Sarah Hanson and Shuna Mason 33 Medical marketing David B. Galloway and Bensita M.V. Thottakam 34 Information and promotion Charles De Wet 35 Economics of health care 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 John P. Griffin and Geoffrey R. Barker 37 Pharmaceutical medicine in the emerging markets Nadarajah Sreeharan, Jennie A. Sykes and Richard B. Nieman 38 Biosimilars Raymond A. Huml and John Posner Appendix 1 Declaration of Helsinki Appendix 2 Agreements and Guidelines for Implementation of Clinical Trials Appendix 3 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 Appendix 4 PharmaTrain Syllabus 2010 Index

• ISBN: 978-0-470-65987-8
• Editorial: Wiley–Blackwell
• Encuadernacion: Cartoné
• Páginas: 854
• Fecha Publicación: 10/05/2013
• Nº Volúmenes: 1
• Idioma: Inglés