The Textbook of Pharmaceutical Medicine / Edition 7

The Textbook of Pharmaceutical Medicine / Edition 7

by John P. Griffin
     
 

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ISBN-10: 0470659874

ISBN-13: 9780470659878

Pub. Date: 06/04/2013

Publisher: Wiley

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

Overview

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

Product Details

ISBN-13:
9780470659878
Publisher:
Wiley
Publication date:
06/04/2013
Pages:
854
Product dimensions:
16.80(w) x 9.80(h) x 1.70(d)

Related Subjects

Table of Contents

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.

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