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

[...]opean 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