Stephens' Detection of New Adverse Drug ReactionsM. D. B. Stephens, John Talbot, Patrick Waller 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 |
Contents
Mechanisms Risk Factors | 91 |
Stephens Detection of New Adverse Drug Reactions Fifth Edition edited by John Talbot and Patrick Waller | 127 |
Collection of Safety Data and Establishing | 167 |
Copyright | |
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Common terms and phrases
ADR reporting ADRs adverse drug reactions adverse events adverse reactions analysis assessment associated Br Med causality cause cell cent CIOMS Clin Pharmacol clinical trials CPMP creatinine database deaths detection disease dose Drug Inf drug safety efficacy enzyme EudraVigilance evaluation example expedited reporting factors guidelines hepatitis hepatotoxicity hormone hospital important incidence increased individual interactions International investigational products investigator laboratory Lancet liver marketing MedDRA medicinal products metabolism method MMR vaccine monitoring normal NSAID occur patients period Pharm pharmaceutical companies pharmaceutical industry Pharmacoepidemiol Drug Saf Pharmacoepidemiology pharmacokinetic pharmacovigilance phase physicians placebo post-marketing potential protein PSUR reference range Regulation regulatory authorities relevant renal response risk safety data serious AEs serious unexpected specific sponsor spontaneous reporting standard statistical studies symptoms Table tests therapeutic therapy toxicity toxicological treatment Uppsala Monitoring Centre vaccine