The Textbook of Pharmaceutical Medicine (eBook)

John Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM; Director, Asklepieion Consultancy Ltd; Visiting Professor, University of Surrey Postgraduate Medical School; Former Director, ABPI; Formerly Professional Head of the Medicines Division, DHSS, London. John Posner BSc PhD MBBS FRCP FFPM; Independent Consultant in Pharmaceutical Medicine, John Posner Consulting, Beckenham, Kent, UK; Chairman of the Board of Examiners of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians (UK). Geoffrey R. Barker TD, BSc, MSc, FDSRCD, FRCS, FFPM; Adj. Professor Immunology, Duke University Medical Center, NC, USA; Executive and Limited Partner, Pappas Ventures, NC, USA; Consultant to EGeen (USA), Abingworth LLP (UK), Reuters; Insight Community of Experts; Trustee Member of the Board of the Faculty of Pharmaceutical Physicians of The Royal Colleges of Physicians UK.

Contributors, xx

The Editors, xx

Acknowledgements, xx

List of Abbreviations, xx

Preface, xx

Part I: Research and Development

1 Discovery of new medicines
Yves J. Ribeill

2 Pharmaceutical development
Michael Gamlen

3 Preclinical safety testing
Lutz Müller, Elisabeth Husar

4 Exploratory development
John Posner

5 Clinical pharmacokinetics
Paul Rolan, Valéria Molnár

6 Biological therapeutics
Peter Lloyd, Jennifer Sims

7 Objectives and design of clinical trials
John Posner, 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, Elizabeth Swain

12 Vaccines
John Beadle

13 Drugs for cancer
James Spicer, Johann De Bono

14 Ethics of human experimentation
Jane Barrett

15 Drug development in paediatrics and neonatology
Nazakat M. Merchant, Denis V. Azzopardi

16 Due diligence and the role of the pharmaceutical physician
Geoffrey R. Barker

Part II: Regulation

17 History of drug regulation
John P. Griffin

18 The clinical trials directive
Fergus Sweeney, Agnès Saint Raymond

19 Human medicinal products in the European Union: Regulations, directives and structures
Agnès Saint Raymond, Anthony J. Humphreys

20 Human medicinal products in the European Union: Procedures
Agnès Saint Raymond, Anthony J. Humphreys

21 European regulation of medical devices
Shuna Mason

22 Paediatric regulation
Heike Rabe, 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, William Vodra

26 Future prospects of the pharmaceutical industry and its regulation in the USA
Richard N. Spivey, William Vodra, Judith K. Jones, William Wardell

27 Regulatory and clinical trial systems in Japan
Mamiko Satake, Natsuko Hosoda

28 The regulation of therapeutic products in Australia
Elizabeth de Somer

Part III: Healthcare marketplace

29 An introduction into lifecycle management of medicines
David Gillen

30 Availability of medicines on-line, counterfeit medicines
Ruth Diazaraque-Marin, David Gillen

31 The supply of unlicensed medicines for individual patient use
Ian Dodds-Smith, Ewan Townsend

32 Legal and ethical issues relating to medicinal products
Nick Bennett, Sarah Hanson, Shuna Mason

33 Medical marketing
David B. Galloway, Bensita M.V.Thottakam

34 Information and promotion
Charles De Wet

35 Economics of health care
Carole A. Bradley, Jane R. Griffin

36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons
John P. Griffin, Geoffrey R. Barker

37 Pharmaceutical medicine in the emerging markets
Nadarajah Sreeharan, Jennie A. Sykes, Richard B. Nieman

Appendix 1 Declaration of Helsinki

Appendix 2 Guidelines and Documentation 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 The Syllabus for Pharmaceutical Medicine

Contributors

"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)