Detection of new adverse drug reactions
This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.
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The Methodology of the Collection of Adverse Event Data
Causality Assessment of Suspected Adverse Drug Reactions
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ABPI ADRs adverse drug reactions adverse event adverse experiences adverse reactions analysis aplastic anaemia Association baseline bilirubin Bulpitt causality assessment cause centres changes chlorpromazine cimetidine CIOMS classification Clin clinical trials clinician cohort studies collection control group COSTART database detect disease doctor dose drug safety drug surveillance Drug-induced Editors effects efficacy evaluation excipients factors follow-up guidelines hospital hypertension identified incidence rate increase individual Inman International investigations laboratory tests Lasagna licensing liver marketing Medicines method Ministry of Health normal NSAIDs number of patients occurring parameters pharmaceutical companies pharmaceutical industry Pharmacoepidemiology pharmacological Pharmacovigilance phase physician placebo population possible post-marketing surveillance practolol pre-marketing prescribing prescription problems protocol published questionnaire rechallenge record reference interval regulations regulatory authorities relevant Research risk scale serious side-effects specific spontaneous reporting standard statistical suspected drug symptoms therapeutic therapy tion treatment values volunteers
Randomised Controlled Clinical Trials, Second Edition
C J Bulpitt
No preview available - 1996
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