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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

Part I: Research and development.

Introduction: the development of pharmaceutical medicine as a specialty (Susan Bews and Huw Jones).

1 Discovery of new medicines (Anand S Dutta).

2 Pharmaceutical development (Gavin Halbert).

3 Preclinical safety testing (Lutz Mueller and David J Tweats).

4 Exploratory development (John Posner).

5 Clinical pharmacokinetics (Paul Rolan and Valeria Rolan).

6 Purpose and design of clinical trials (Roger A Yates and Steve Warrington).

7 Conduct of clinical trials: good clinical practice (Roger A Yates and Steve Warrington).

8 Medical statistics (Andrew P Grieve).

9 Development of medicines: full development (Alan G Davies and Peter D Stonier).

Part II: Medical department issues.

10 The medical department (Peter D Stonier).

11 Medical marketing (David Galloway).

12 Information and promotion (Charles de Wet).

13 The supply of unlicensed medicines for particular patient use (Ian Dodds-Smith, Amanda Wearing and John O'Grady).

14 Ethics of human experimentation (Duncan Vere).

15 Legal and ethical issues relating to medicinal products (David Marks, Nick Beckett, Sarah Hanson and Shuna Mason).

16 The safety of medical products (A. Peter Fletcher and Susan Shaw).

Part III: Regulatory aspects.

17 History of drug regulation in the United Kingdom (John P Griffin and Rashmi R Shah).

18 Regulation of human medicinal products in the European Union (John P Griffin and Rashmi R Shah).

19 Paediatric regulation (Heike Rabe).

20 European regulation of medical devices (Christopher JS Hodges).

21 Technical requirements for registration of pharmaceuticals for human use: the ICH process (Dean W G Harron).

22 The regulation of drug products by the United States Food and Drug Administration (Peter Barton Hutt).

23 The US FDA in the drug development, evaluation and approval process (Richard N Spivey, Judith K Jones, William Wardell and William Vodra).

24 Past evolution and future prospects of the Pharma Industry and its regulation in the USA (William Wardell, William Vodra, Judith K Jones and Richard N Spivey).

25 Regulatory and clinical trial systems in Japan (Yuichi Kubo).

26 The regulation of therapeutic products in Australia (Janice Hirshorn and Deborah Monk).

27 Pharmaceutical medicine in emerging markets (N. Shreeharan).

Part IV: Pharmacoeconomic and other issues.

28 Economics of healthcare (Carole Bradley-Kennedy and Jane R Griffin).

29 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons (John P Griffin and Jane R Griffin).

30 Due diligence and the pharmaceutical physician (Geoff Barker).

Appendix 1 Declaration of Helsinki.

Appendix 2 Code of Practice for the Pharmaceutical Industry.

Appendix 3 Guidelines and Documentation for Implementation of Clinical Trials.

Appendix 4 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001.

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