Chapter 15. The Safety of Medical Products
- John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
- John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
Published Online: 25 OCT 2007
DOI: 10.1002/9780470987391.ch15
© 2006 by Blackwell Publishing Ltd.
Book Title
The Textbook of Pharmaceutical Medicine, Fifth Edition
Additional Information
How to Cite
Fletcher, A. P. and Shaw, S. (2007) The Safety of Medical Products, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch15
Editor Information
- 1
Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London
- 2
Visiting Professor of Clinical Pharmacology, University of London
Publication History
- Published Online: 25 OCT 2007
- Published Print: 15 DEC 2005
ISBN Information
Print ISBN: 9780727918406
Online ISBN: 9780470987391
- Summary
- Chapter
- References
Keywords:
- product safety;
- clinical medicine;
- adverse drug reactions;
- COX 2 inhibitor;
- committee on safety of medicines
Summary
This chapter contains sections titled:
Introduction
The Concept of Safety
General Considerations
Methods of Postmarketing Safety Evaluation
Clinical Trials
Spontaneous Event Reporting
Computerised Databases
Case-Control Studies
Prescription Event Monitoring
Some Examples
Causality Assessment
The Legal Framework and its Implications for Future International Developments
Other Considerations and Conclusions