The Textbook of Pharmaceutical Medicine / Edition 7

The Textbook of Pharmaceutical Medicine / Edition 7

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The Textbook of Pharmaceutical Medicine / Edition 7

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

Product Details

ISBN-13: 9780470659878
Publisher: Wiley
Publication date: 06/04/2013
Pages: 854
Product dimensions: 16.80(w) x 9.80(h) x 1.70(d)

About 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

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 physician306
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: RegulationsDirectives and structures 360
Agnès Saint Raymond and Anthony J. Humphreys

20 Human medicinal products in the European Union: Procedures379
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 pharmaceuticalsfor human use: The ICH process 447
Dean W.G. Harron

24 The regulation of drug products by the US Food and DrugAdministration 461
Peter Barton Hutt

25 The US FDA in the drug development evaluation and approvalprocess 501
Richard N. Spivey Judith K. Jones William Wardell and William W.Vodra

26 Future prospects of the pharmaceutical industry and itsregulation in the USA 518
Richard N. Spivey William W. Vodra Judith K. Jones and WilliamWardell

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 medicines589
David Gillen

30 Availability of medicines online and counterfeit medicines597
Ruth Diazaraque and David Gillen

31 The supply of unlicensed medicines for individual patient use610
Ian Dodds-Smith and Ewan Townsend

32 Legal and ethical issues relating to medicinal products632
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 theUK (a historical perspective) with some international comparisons707
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 ofClinical Trials 755

Appendix 3 Directive 2001/20/EC of the European Parliament andof the Council of 4 April 2001 771

Appendix 4 PharmaTrain Syllabus 2010 783

Index 788

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