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What is included with this book?
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 DevelopmentPart II: RegulationPart III: Healthcare marketplaceView Table of Contents in detail
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 medicinesYves J. Ribeill
2 Pharmaceutical developmentMichael Gamlen
3 Preclinical safety testingLutz Müller, Elisabeth Husar
4 Exploratory developmentJohn Posner
5 Clinical pharmacokineticsPaul Rolan, Valéria Molnár
6 Biological therapeuticsPeter Lloyd, Jennifer Sims
7 Objectives and design of clinical trialsJohn Posner, Steve Warrington
8 Conduct of clinical trials: good clinical practiceKate L.R. Darwin
9 Medical statisticsAndrew P. Grieve
10 Development of medicines: full developmentPeter D. Stonier
11 PharmacovigilanceStephen F. Hobbiger, Bina Patel, Elizabeth Swain
12 VaccinesJohn Beadle
13 Drugs for cancerJames Spicer, Johann De Bono
14 Ethics of human experimentationJane Barrett
15 Drug development in paediatrics and neonatologyNazakat M. Merchant, Denis V. Azzopardi
16 Due diligence and the role of the pharmaceutical physicianGeoffrey R. Barker
Part II: Regulation
17 History of drug regulationJohn P. Griffin
18 The clinical trials directiveFergus Sweeney, Agnès Saint Raymond
19 Human medicinal products in the European Union: Regulations, directives and structuresAgnès Saint Raymond, Anthony J. Humphreys
20 Human medicinal products in the European Union: ProceduresAgnès Saint Raymond, Anthony J. Humphreys
21 European regulation of medical devicesShuna Mason
22 Paediatric regulationHeike Rabe, Agnès Saint Raymond
23 Technical requirements for registration of pharmaceuticals for human use: the ICH processDean W.G. Harron
24 The regulation of drug products by the US Food and Drug AdministrationPeter Barton Hutt
25 The US FDA in the drug development evaluation and approval processRichard N. Spivey, Judith K. Jones, William Wardell, William Vodra
26 Future prospects of the pharmaceutical industry and its regulation in the USARichard N. Spivey, William Vodra, Judith K. Jones, William Wardell
27 Regulatory and clinical trial systems in JapanMamiko Satake, Natsuko Hosoda
28 The regulation of therapeutic products in AustraliaElizabeth de Somer
Part III: Healthcare marketplace
29 An introduction into lifecycle management of medicinesDavid Gillen
30 Availability of medicines on-line, counterfeit medicinesRuth Diazaraque-Marin, David Gillen
31 The supply of unlicensed medicines for individual patient useIan Dodds-Smith, Ewan Townsend
32 Legal and ethical issues relating to medicinal productsNick Bennett, Sarah Hanson, Shuna Mason
33 Medical marketing David B. Galloway, Bensita M.V.Thottakam
34 Information and promotionCharles De Wet
35 Economics of health careCarole A. Bradley, Jane R. Griffin
36 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisonsJohn P. Griffin, Geoffrey R. Barker
37 Pharmaceutical medicine in the emerging marketsNadarajah 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
The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.
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