The Textbook of Pharmaceutical Medicine, 6th Edition

Copyright © 2009 Blackwell Publishing Ltd

The Textbook of Pharmaceutical Medicine, 6th Edition

Editor(s): John P. Griffin

Published Online: 18 NOV 2009

Print ISBN: 9781405180351

Online ISBN: 9781444317800

DOI: 10.1002/9781444317800

About this Book

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About The Product

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 these vital new areas:

  • Paediatric regulation
  • Ethics
  • Due diligence and the pharmaceutical physician

Table of contents

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      Front Matter (pages i–xv)

  2. Part I: Research and Development

    1. Chapter 1

      Discovery of New Medicines (pages 1–80)

      Anand S. Dutta

    2. Chapter 2

      Pharmaceutical Development (pages 81–100)

      Gavin Halbert

    3. Chapter 3

      Preclinical Safety Testing (pages 101–136)

      Lutz Müller and Anke Lühe

    4. Chapter 4

      Exploratory Development (pages 137–166)

      John Posner

    5. Chapter 5

      Clinical Pharmacokinetics (pages 167–184)

      Paul Rolan and Valèria Molnár

    6. Chapter 6

      Purpose and Design of Clinical Trials (pages 185–206)

      Steve Warrington

    7. Chapter 7

      Conduct of Clinical Trials: Good Clinical Practice (pages 207–239)

      Kate L. R. Darwin

    8. Chapter 8

      Medical Statistics (pages 240–269)

      Andrew P. Grieve

    9. Chapter 9

      Development of Medicines: Full Development (pages 270–284)

      Peter D. Stonier

  3. Part II: Medical Department Issues

    1. Chapter 10

      The Medical Department (pages 285–295)

      Peter Stonier and David Gillen

    2. Chapter 11

      Medical Marketing (pages 296–309)

      David Galloway and Bensita Bernard

    3. Chapter 12

      Information and Promotion (pages 310–330)

      Charles de Wet

    4. Chapter 13

      The Supply of Unlicensed Medicines for Individual Patient use (pages 331–346)

      Ian Dodds-Smith and Silvia Valverde

    5. Chapter 14

      Human Experimentation – Ethics of First Human Exposure (pages 347–350)

      Duncan W. Vere

    6. Chapter 15

      Legal and Ethical Issues Relating to Medicinal Products (pages 351–371)

      Nick Beckett, Sarah Hanson, Christopher J. S. Hodges and Shuna Mason

    7. Chapter 16

      The Safety of Medical Products (pages 372–409)

      A. Peter Fletcher and Susan Shaw

  4. Part III: Regulatory Aspects

    1. Chapter 17

      History of Drug Regulation in the UK (pages 411–443)

      John P. Griffin

    2. Chapter 18

      Regulation of Human Medicinal Products in the European Union (pages 444–499)

      Rashmi R. Shah and Agnès Saint Raymond

    3. Chapter 19

      Paediatric Regulation (pages 500–506)

      Heike Rabe

    4. Chapter 20

      European Regulation of Medical Devices (pages 507–521)

      Christopher J. S. Hodges

    5. Chapter 21

      Technical Requirements for Registration of Pharmaceuticals for Human use: the ICH Process (pages 522–533)

      Dean W. G. Harron

    6. Chapter 22

      The Regulation of Drug Products by the US Food and Drug Administration (pages 534–566)

      Peter Barton Hutt

    7. Chapter 23

      The US FDA in the Drug Development, Evaluation and Approval Process (pages 567–584)

      Richard N. Spivey, Judith K. Jones, William Wardell and William Vodra

    8. Chapter 24

      Future Prospects of the Pharmaceutical Industry and its Regulation in the USA (pages 585–601)

      William Wardell, Judith K. Jones, Richard N. Spivey and William Vodra

    9. Chapter 25

      Regulatory and Clinical Trial Systems in Japan (pages 602–612)

      Yuichi Kubo

    10. Chapter 26

      The Regulation of Therapeutic Products in Australia (pages 613–640)

      Janice Hirshorn and Deborah Monk

    11. Chapter 27

      Pharmaceutical Medicine in the Emerging Markets (pages 641–657)

      Nadarajah Sreeharan and Jennie A. Sykes

  5. Part IV: Pharmacoeconomic and Other Issues

    1. Chapter 28

      Economics of Health Care (pages 661–673)

      Carole A. Bradley and Jane R. Griffin

    2. Chapter 29

      Controls on NHS Medicines Prescribing and Expenditure in the UK (a Historical Perspective) with some International Comparisons (pages 674–690)

      John P. Griffin and Jane R. Griffin

    3. Chapter 30

      Due Diligence and the Role of the Pharmaceutical Physician (pages 691–699)

      Geoffrey R. Barker

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      Appendix 1: Declaration of Helsinki (pages 700–703)

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      Appendix 2: Guidelines and Documentation for Implementation of Clinical Trials (pages 704–728)

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      Appendix 3: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 (pages 729–739)

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      Appendix 4: The Syllabus for Pharmaceutical Medicine (pages 740–743)

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      Index (pages 744–758)

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