Table of contents for The textbook of pharmaceutical medicine / [edited by] John Parry Griffin.


Bibliographic record and links to related information available from the Library of Congress catalog


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Part I: Research and development.
Introduction: the development of pharmaceutical medicine as a specialty - Susan Bews and Huw Jones.
1 Discovery of new medicines - Anand S Dutta.
2 Pharmaceutical development - Gavin Halbert.
3 Preclinical safety testing - Lutz Mueller and David J Tweats.
4 Exploratory development - John Posner.
5 Clinical pharmacokinetics - Paul Rolan and Valeria Rolan.
6 Purpose and design of clinical trials - Roger A Yates and Steve Warrington.
7 Conduct of clinical trials: good clinical practice - Roger A Yates and Steve Warrington.
8 Medical statistics - Andrew P Grieve.
9 Development of medicines: full development - Alan G Davies and Peter D Stonier.
Part II: Medical department issues.
10 The medical department - Peter D Stonier.
11 Medical marketing - David Galloway.
12 Information and promotion - Charles de Wet.
13 The supply of unlicensed medicines for particular patient use - Ian Dodds-Smith, Amanda Wearing and John O’ Grady.
14 Ethics of human experimentation - Duncan Vere.
15 Legal and ethical issues relating to medicinal products - David Marks, Nick Beckett, Sarah Hanson and Shuna Mason.
16 The safety of medical products - A. Peter Fletcher and Susan Shaw.
Part III: Regulatory aspects.
17 History of drug regulation in the United Kingdom - John P Griffin and Rashmi R Shah.
18 Regulation of human medicinal products in the European Union - John P Griffin and Rashmi R Shah.
19 Paediatric regulation - Heike Rabe.
20 European regulation of medical devices - Christopher JS Hodges.
21 Technical requirements for registration of pharmaceuticals for human use: the ICH process - Dean W G Harron.
22 The regulation of drug products by the United States Food and Drug Administration - Peter Barton Hutt.
23 The US FDA in the drug development, evaluation and approval process - Richard N Spivey, Judith K Jones, William Wardell and William Vodra.
24 Past evolution and future prospects of the Pharma Industry and its regulation in the USA - William Wardell, William Vodra, Judith K Jones and Richard N Spivey.
25 Regulatory and clinical trial systems in Japan - Yuichi Kubo.
26 The regulation of therapeutic products in Australia - Janice Hirshorn and Deborah Monk.
27 Pharmaceutical medicine in emerging markets - N. Shreeharan.
Part IV: Pharmacoeconomic and other issues.
28 Economics of healthcare - Carole Bradley-Kennedy and Jane R Griffin.
29 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons - John P Griffin and Jane R Griffin.
30 Due diligence and the pharmaceutical physician - Geoff Barker.
Appendix 1 Declaration of Helsinki.
Appendix 2 Code of Practice for the Pharmaceutical Industry.
Appendix 3 Guidelines and Documentation for Implementation of Clinical Trials.
Appendix 4 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001


Library of Congress subject headings for this publication:
Pharmacology, Experimental.
Drug Approval.
Clinical Trials as Topic.
Pharmacology.