Griffin / Posner / Barker The Textbook of Pharmaceutical Medicine

7. Auflage 2013
ISBN: 978-1-118-53235-5
Verlag: John Wiley & Sons
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 856 Seiten, E-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 Development
Part II: Regulation
Part III: Healthcare marketplace
View Table of Contents in detail

Autoren/Hrsg.

Griffin, John P.

Posner, John

Barker, Geoffrey R.

Inhaltsverzeichnis

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