Librería Servicio Médico

Author : P. Griffin / R. Barker / Posner

Language: English

Finishing : Hardcover, 854 pages

ISBN : 978-0-470-65987-8

Edition Number: 7/2013

Description:

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

Table Of Contents:

• 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
• Yves J. Ribeill
• 2 Pharmaceutical development 32
• Michael Gamlen and Paul Cummings
• 3 Preclinical safety testing 42
• Lutz Müller and Elisabeth Husar
• 4 Exploratory development 82
• John Posner
• 5 Clinical pharmacokinetics 113
• Paul Rolan and Valéria Molnár
• 6 Biological therapeutics 132
• Peter Lloyd and Jennifer Sims
• 7 Objectives and design of clinical trials 143
• John Posner and Steve Warrington
• 8 Conduct of clinical trials: Good Clinical Practice 155
• Kate L.R. Darwin
• 9 Medical statistics 189
• Andrew P. Grieve
• 10 Development of medicines: full development 219
• Peter D. Stonier
• 11 Pharmacovigilance 235
• Stephen F. Hobbiger Bina Patel and Elizabeth Swain
• 12 Vaccines 254
• John Beadle
• 13 Drugs for cancer 270
• James Spicer and Johann De Bono
• 14 Ethics of human experimentation 286
• Jane Barrett
• 15 Drug development in paediatrics and neonatology 295
• Nazakat M. Merchant and Denis V. Azzopardi
• 16 Due diligence and the role of the pharmaceutical physician 306
• Geoffrey R. Barker

Part II Regulation 317

• 17 A history of drug regulation in the UK 319
• John P. Griffin
• 18 The Clinical Trials Directive 347
• Fergus Sweeney and Agnès Saint Raymond
• 19 Human medicinal products in the European Union: Regulations Directives and structures 360
• Agnès Saint Raymond and Anthony J. Humphreys
• 20 Human medicinal products in the European Union: Procedures 379
• Agnès Saint Raymond and Anthony J. Humphreys
• 21 European regulation of medical devices 418
• Shuna Mason
• 22 Paediatric regulation 435
• Heike Rabe and Agnès Saint-Raymond
• 23 Technical requirements for registration of pharmaceuticals for human use: The ICH process 447
• Dean W.G. Harron
• 24 The regulation of drug products by the US Food and Drug Administration 461
• Peter Barton Hutt
• 25 The US FDA in the drug development evaluation and approval process 501
• 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 518
• Richard N. Spivey William W. Vodra Judith K. Jones and William Wardell
• 27 Regulatory and clinical trial systems in Japan 537
• Mamiko Satake and Natsuko Hosoda
• 28 The regulation of therapeutic products in Australia 554
• Elizabeth de Somer Deborah Monk and Janice Hirshorn

Part III Health care marketplace 587

• 29 An Introduction to life cycle management of medicines 589
• David Gillen
• 30 Availability of medicines online and counterfeit medicines 597
• Ruth Diazaraque and David Gillen
• 31 The supply of unlicensed medicines for individual patient use 610
• Ian Dodds-Smith and Ewan Townsend
• 32 Legal and ethical issues relating to medicinal products 632
• Nick Beckett Sarah Hanson and Shuna Mason
• 33 Medical marketing 653
• David B. Galloway and Bensita M.V. Thottakam
• 34 Information and promotion 670
• Charles De Wet
• 35 Economics of health care 692
• 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 707
• John P. Griffi n and Geoffrey R. Barker
• 37 Pharmaceutical medicine in the emerging markets 728
• Nadarajah Sreeharan Jennie A. Sykes and Richard B. Nieman
• 38 Biosimilars 744
• Raymond A. Huml and John Posner
• 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

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