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The Textbook of Pharmaceutical Medicine
John P. Griffin (Edited by), JP Griffin (Author), John Posner (Edited by), Geoffrey R. Barker (Edited by)
9780470659878, Wiley
Hardback, published 10 May 2013
856 pages
24.9 x 17.3 x 4.8 cm, 1.61 kg
“This comprehensive volume covers the processes by which medicines are developed, tested and approved. The chapters are written by leading academics, medical directors and legal experts in the field of harmaceutical medicine and provide authorative and in-depth information for both physicians working in and those who are currently training in the pharmaceutical industry.” (British Journal of Clinical Pharmacology, 22 April 2014) “This book is expected to be useful for pharmaceutical physicians and for anyone interested in learning about the various issues in drug discovery and development. In addition to many other topics, the regulatory aspects of drug development in the U.S., Europe, and Japan are well covered . . . Nevertheless, this is an admirable effort and the book deserves a place on the bookshelves of pharmaceutical physicians. ” (Doody’s, 30 August 2013)
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
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 2 Pharmaceutical development 32 3 Preclinical safety testing 42 4 Exploratory development 82 5 Clinical pharmacokinetics 113 6 Biological therapeutics 132 7 Objectives and design of clinical trials 143 8 Conduct of clinical trials: Good Clinical Practice 155 9 Medical statistics 189 10 Development of medicines: full development 219 11 Pharmacovigilance 235 12 Vaccines 254 13 Drugs for cancer 270 14 Ethics of human experimentation 286 15 Drug development in paediatrics and neonatology 295 16 Due diligence and the role of the pharmaceutical physician 306 Part II Regulation 317 17 A history of drug regulation in the UK 319 18 The Clinical Trials Directive 347 19 Human medicinal products in the European Union: Regulations Directives and structures 360 20 Human medicinal products in the European Union: Procedures 379 21 European regulation of medical devices 418 22 Paediatric regulation 435 23 Technical requirements for registration of pharmaceuticals for human use: The ICH process 447 24 The regulation of drug products by the US Food and Drug Administration 461 25 The US FDA in the drug development evaluation and approval process 501 26 Future prospects of the pharmaceutical industry and its regulation in the USA 518 27 Regulatory and clinical trial systems in Japan 537 28 The regulation of therapeutic products in Australia 554 Part III Health care marketplace 587 29 An Introduction to life cycle management of medicines 589 30 Availability of medicines online and counterfeit medicines 597 31 The supply of unlicensed medicines for individual patient use 610 32 Legal and ethical issues relating to medicinal products 632 33 Medical marketing 653 34 Information and promotion 670 35 Economics of health care 692 36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons 707 37 Pharmaceutical medicine in the emerging markets 728 38 Biosimilars 744 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
Yves J. Ribeill
Michael Gamlen and Paul Cummings
Lutz Müller and Elisabeth Husar
John Posner
Paul Rolan and Valéria Molnár
Peter Lloyd and Jennifer Sims
John Posner and Steve Warrington
Kate L.R. Darwin
Andrew P. Grieve
Peter D. Stonier
Stephen F. Hobbiger, Bina Patel and Elizabeth Swain
John Beadle
James Spicer and Johann De Bono
Jane Barrett
Nazakat M. Merchant and Denis V. Azzopardi
Geoffrey R. Barker
John P. Griffin
Fergus Sweeney and Agnès Saint Raymond
Agnès Saint Raymond and Anthony J. Humphreys
Agnès Saint Raymond and Anthony J. Humphreys
Shuna Mason
Heike Rabe and Agnès Saint-Raymond
Dean W.G. Harron
Peter Barton Hutt
Richard N. Spivey, Judith K. Jones, William Wardell and William W. Vodra
Richard N. Spivey, William W. Vodra, Judith K. Jones and William Wardell
Mamiko Satake and Natsuko Hosoda
Elizabeth de Somer, Deborah Monk and Janice Hirshorn
David Gillen
Ruth Diazaraque and David Gillen
Ian Dodds-Smith and Ewan Townsend
Nick Beckett, Sarah Hanson and Shuna Mason
David B. Galloway and Bensita M.V. Thottakam
Charles De Wet
Carole A. Bradley and Jane R. Griffin
John P. Griffin and Geoffrey R. Barker
Nadarajah Sreeharan, Jennie A. Sykes and Richard B. Nieman
Raymond A. Huml and John Posner
Subject Areas: Other branches of medicine [MM]
