Stephens' Detection of New Adverse Drug Reactions

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M. D. B. Stephens, John Talbot, Patrick Waller
John Wiley & Sons, 2004 - Medical - 745 pages
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Key text for all those involved in pharmacovigilance.

Detection of new adverse drug reactions is fundamental to theprotection of patients from harm that may occur as a result ofmedication. This book explores the methods used to investigate newadverse drug reactions, discussing all elements from the scientificbackground and animal toxicology through to worldwide regulatoryand ethical issues.

Stephens’ Detection of New Adverse Drug Reactionsprovides comprehensive, in-depth, up-to-date coverage of materialfundamentally important to all those active in the field, whetherthey work in the pharmaceutical industry, drug regulatoryauthorities or in academia.

The fifth edition of this classic reference work includes newchapters on:

  • vaccine safety surveillance
  • managing drug safety issues with marketed products
  • operational aspects of drug safety function
  • safety of biotechnology products
  • future of pharmacovigilance

Reviews of previous editions:

"This book surpasses all its educational aims. Not only is thesubject matter covered comprehensively but the material ispresented in a very user-friendly manner. The editors havesucceeded in producing a highly-specific, definitive reference bookwhich doubles as a most enjoyable read."
Comended by the 1999 BMA Medical Book Competition

"For anyone entering the field of adverse reaction monitoringone could not wish for a better primer"
International Journal of Risk and Safety inMedicine

 

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Contents

Mechanisms Risk Factors
91
Management of adverse drug reactions
108
Conclusions
122
Stephens Detection of New Adverse Drug Reactions Fifth Edition edited by John Talbot and Patrick Waller
127
Drug development
137
Adverse drug reactions detected after authorization
150
Collection of Safety Data and Establishing
167
Final analysis of data
229
risk management
369
The European Union
399
The United Kingdom
419
United States of America
432
Legal Aspects of Pharmacovigilance
453
Operational Aspects of the Drug Safety Function within
493
Dictionaries and Coding in Pharmacovigilance
533
Safety of Biotechnology Products
559

Clinical Laboratory Safety Data in Drug Studies
243
Reference ranges
256
Test selection
289
Analysis and Presentation of Safety Data
301
Use of statistical methods for signal detection with spontaneous reports
316
Causality and Correlation in Pharmacovigilance
329
Conclusion
342
Investigation
356
Vaccine Safety Surveillance
571
Ethical Issues in Drug Safety
591
A Model for the Future Conduct of Pharmacovigilance
649
Appendix I
667
Appendix II
705
Index
721
Copyright

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Page 449 - April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (the Clinical Trials Directive).
Page 449 - January 1965 on the approximation of provisions laid down by law, regulation, or administrative action relating to proprietary medicinal products as extended, widened, and amended.

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