The Textbook of Pharmaceutical Medicine / Edition 5

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"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 vital new areas.

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Editorial Reviews

Doody's Review Service
Reviewer: Scott J Weir, PharmD, PhD (University of Kansas Medical Center)
Description: This is a book for pharmaceutical and medical related sciences programs in the U.K. The first edition was published in 1993.
Purpose: The purpose is to educate its readers on drug discovery and development. The book is broken down into four appropriate sections or parts: research and development, medical, regulatory, and pharmacoeconomics.
Audience: It is written for students, either in medicine or pharmaceutical sciences, pursuing advanced degrees. There are many contributing authors to this text book.
Features: The structure and content of the book is at an appropriate level. I found the U.K. perspectives helpful, but wonder whether U.S. students may be turned off a bit by the European viewpoint.
Assessment: The quality of the book is fine. It is written at a pretty high level, more for students than experts in the field of drug discovery and development.
From the Publisher
“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)

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Product Details

  • ISBN-13: 9780727918406
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 2/28/2006
  • Edition description: REV
  • Edition number: 5
  • Pages: 880
  • Product dimensions: 7.00 (w) x 10.00 (h) x 1.90 (d)

Meet the Author

John Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM
Director, Asklepieion Consultancy Ltd; Visiting Professor, Unviersity of Surrey Postgraduate Medical School; Former Director, ABPI; Formerly Professional Head of the Medicines Division, DHSS, London

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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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