Stephens' Detection of New Adverse Drug Reactions
M. D. B. Stephens, John Talbot, Patrick Waller
John Wiley & Sons, 2004 - Medical - 745 pages
A key text for all those involved in pharmacovigilance.
Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues.
Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia.
The fifth edition of this classic reference work includes new chapters on:
Reviews of previous editions:
"This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read."
"For anyone entering the field of adverse reaction monitoring one could not wish for a better primer"
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Mechanisms Risk Factors
Management of adverse drug reactions
Stephens Detection of New Adverse Drug Reactions Fifth Edition edited by John Talbot and Patrick Waller
Adverse drug reactions detected after authorization
Collection of Safety Data and Establishing
Final analysis of data
The European Union
The United Kingdom
United States of America
Legal Aspects of Pharmacovigilance
Operational Aspects of the Drug Safety Function within
Dictionaries and Coding in Pharmacovigilance
Safety of Biotechnology Products
Clinical Laboratory Safety Data in Drug Studies
Analysis and Presentation of Safety Data
Use of statistical methods for signal detection with spontaneous reports
Causality and Correlation in Pharmacovigilance