The Textbook of Pharmaceutical Medicine / Edition 7

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Overview

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

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Editorial Reviews

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)

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.
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Product Details

  • ISBN-13: 9780470659878
  • Publisher: Wiley
  • Publication date: 6/4/2013
  • Edition number: 7
  • Pages: 854
  • Product dimensions: 16.80 (w) x 9.80 (h) x 1.70 (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

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

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