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 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, in-depth, 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:
* 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 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." - Comended by the 1999 BMA Medical Book Competition
"For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" - International Journal of Risk and Safety in Medicine
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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
Other editions - View all
ADR reporting ADRs adverse drug reactions adverse events adverse reactions analysis aplastic anaemia assessment associated causality cause cell cent CIOMS Clin Pharmacol clinical trials CPMP creatinine database detection disease dose drug safety effects efficacy enzyme ethics EudraVigilance evaluation example expedited reporting factors guidelines hepatitis hepatotoxicity hormone hospital important increase individual interactions International investigational products investigator laboratory Lancet liver marketing measures MedDRA medicinal products metabolism method MMR vaccine monitoring normal NSAID occur patients pharmaceutical companies Pharmacoepidemiol Drug Pharmacoepidemiology pharmacokinetic pharmacological pharmacovigilance phase physicians placebo plasma possible post-marketing potential prescribing protein PSUR reference range regulations regulatory authorities relevant renal requirements response risk safety data serious AEs serious unexpected specific sponsor spontaneous reporting statistical studies symptoms syndrome Table tests therapeutic therapy toxicity toxicology treatment Uppsala Monitoring Centre vaccine warfarin
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).