Stephens' Detection of New Adverse Drug Reactions
M. D. B. Stephens, John Talbot, Patrick Waller
John Wiley & Sons, 2004 - Medical - 745 pages
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:
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."
"For anyone entering the field of adverse reaction monitoringone 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