Detection of New Adverse Drug ReactionsM. D. B. Stephens, J. C. C. Talbot, Philip Routledge 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. |
Contents
Mechanisms Risk Factors | 59 |
Toxicology and Adverse Drug Reactions | 87 |
Methodology for the Collection of Adverse Event Data in Clinical | 97 |
Copyright | |
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Common terms and phrases
abnormal adverse drug reactions adverse event adverse reactions Agranulocytosis analysis aplastic anaemia associated baseline beta blockers bilirubin cause centres changes chlorpromazine CIOMS Clin clinical trials COSTART CPMP database dechallenge detect disease dose Drug Inf Drug Safety Drug-induced Epidemiology ethical evaluation factors guidelines hepatic hospital incidence increase individual interactions International investigations investigator's brochure laboratory data liver marketing measure MedDRA medicinal products metabolism method monitoring normal NSAID number of patients occur parameters pharmaceutical companies Pharmacoepidemiology pharmacokinetic Pharmacol pharmacological pharmacovigilance phase physician placebo population possible post-marketing prescribing problems protocol questionnaire questions reference interval regulations regulatory authorities relevant renal response risk safety data scale side effects specific spontaneous reports Spriet standard statistical studies survey symptoms syndrome therapeutic therapy tion toxicity treatment trialist type A reactions visual analogue scale volunteers warfarin weeks