Detection of New Adverse Drug ReactionsThis 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. |
Contents
The Methodology of the Collection of Adverse Event Data | 37 |
Laboratory Investigations | 71 |
Causality Assessment of Suspected Adverse Drug Reactions | 116 |
Copyright | |
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Common terms and phrases
ADRs adverse drug reactions adverse event adverse experiences adverse reactions Agranulocytosis analysis aplastic anaemia Association baseline Bulpitt causality assessment cause centres changes chlorpromazine cimetidine CIOMS Clin clinical trials cohort studies collection control group COSTART database detect diagnosis disease doctor dose Drug Inf drug safety drug surveillance Drug-induced Editors effects evaluation excipients factors follow-up guidelines hospital hypertension identified incidence rate increase individual Inman International investigations laboratory tests Lasagna licensing marketing Medicines method Ministry of Health normal number of patients occurring parameters pharmaceutical companies pharmaceutical industry Pharmacoepidemiology pharmacological Pharmacovigilance phase physician placebo PMS schemes 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