The Textbook of Pharmaceutical Medicine, Fifth Edition

© 2006 by Blackwell Publishing Ltd.

The Textbook of Pharmaceutical Medicine, Fifth Edition

Editor(s): John P Griffin, John O'Grady

Published Online: 25 OCT 2007

Print ISBN: 9780727918406

Online ISBN: 9780470987391

DOI: 10.1002/9780470987391

Table of contents

    1. You have free access to this content
      Frontmatter (pages i–x)

  2. Part I: Research and Development

    1. Chapter 1

      Discovery of New Medicines (pages 1–86)

      Anand S Dutta

    2. Chapter 2

      Pharmaceutical Development (pages 87–110)

      Gavin Halbert

    3. Chapter 3

      Preclinical Safety Testing (pages 111–143)

      David J Tweats

    4. Chapter 4

      Exploratory Development (pages 144–175)

      John Posner

    5. Chapter 5

      Clinical Pharmacokinetics (pages 176–197)

      Paul Rolan and Valeria Molnar

    6. Chapter 6

      Purpose and Design of Clinical Trials (pages 198–238)

      Roger A Yates

    7. Chapter 7

      Conduct of Clinical Trials: Good Clinical Practice (pages 239–274)

      Roger A Yates

    8. Chapter 8

      Medical Statistics (pages 275–309)

      Andrew P Grieve

    9. Chapter 9

      Development of Medicines: Full Development (pages 310–328)

      Alan G Davies and Peter D Stonier

  3. Part II: Medical Department Issues

    1. Chapter 10

      The Medical Department (pages 330–339)

      Darrall L Higson and PD Stonier

    2. Chapter 11

      Medical Marketing (pages 340–354)

      John H Young

    3. Chapter 12

      Information and Promotion (pages 355–379)

      D Michael Humphreys

    4. Chapter 13

      The Supply of Unlicensed Medicines for Particular Patient Use (pages 380–389)

      Amanda Wearing and John O'Grady

    5. Chapter 14

      Legal and Ethical Issues Relating to Medicinal Products (pages 390–409)

      Christine H Bendall and Christopher JS Hodges

    6. Chapter 15

      The Safety of Medical Products (pages 410–453)

      A Peter Fletcher and Susan Shaw

  4. Part III: Regulatory Aspects

    1. Chapter 16

      History of Drug Regulation in the United Kingdom (pages 456–488)

      John P Griffin and Rashmi R Shah

    2. Chapter 17

      Regulation of Human Medicinal Products in the European Union (pages 489–534)

      Rashmi R Shah and John P Griffin

    3. Chapter 18

      European Regulation of Medical Devices (pages 535–551)

      Christopher JS Hodges

    4. Chapter 19

      Technical Requirements for Registration of Pharmaceuticals for Human Use: the ICH Process (pages 552–564)

      Dean WG Harron

    5. Chapter 20

      The Regulation of Drug Products by the United States Food and Drug Administration (pages 565–601)

      Peter Barton Hutt

    6. Chapter 21

      The US FDA in the Drug Development, Evaluation and Approval Process (pages 602–613)

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

    7. Chapter 22

      Past Evolution and Future Prospects of the Pharma Industry and its Regulation in the USA (pages 614–636)

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

    8. Chapter 23

      Regulatory and Clinical Trial Systems in Japan (pages 637–651)

      Yuichi Kubo

    9. Chapter 24

      The Regulation of Therapeutic Products in Australia (pages 652–684)

      Janice Hirshorn and Deborah Monk

  5. Part IV: Pharmacoeconomic and Other Issues

    1. Chapter 25

      Economics of Healthcare (pages 686–701)

      Carole Bradley and Jane R Griffin

    2. Chapter 26

      Controls on NHS Medicines Prescribing and Expenditure in the UK (A Historical Perspective) with some International Comparisons (pages 702–719)

      John P Griffin and Jane R Griffin

    1. You have free access to this content
      Appendix 1: Declaration of Helsinki (pages 721–726)

    1. You have free access to this content
      Appendix 2: Code of Practice for the Pharmaceutical Industry (pages 728–787)

    1. You have free access to this content
      Appendix 3: Guidelines and Documentation for Implementation of Clinical Trials (pages 788–826)

    1. You have free access to this content
      Appendix 4: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 (pages 827–843)

    1. You have free access to this content
      Index (pages 845–870)

SEARCH