Detection of New Adverse Drug Reactions
M. D. B. Stephens, J. C. C. Talbot, Philip Routledge
Macmillan Reference, 1998 - Medical - 546 pages
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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Mechanisms Risk Factors
Toxicology and Adverse Drug Reactions
Methodology for the Collection of Adverse Event Data in Clinical
15 other sections not shown
abnormal ADRs adverse drug reactions adverse event adverse reactions analysis aplastic anaemia associated baseline benzodiazepines beta blockers bilirubin cause centres changes chlorpromazine CIOMS clinical trials Committee COSTART CPMP creatinine data sheet database dechallenge detect digoxin disease doctor dose Drug Safety Drug-induced efficacy epidemiological 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 NSAIDs number of patients occur parameters pharmaceutical companies Pharmacoepidemiology pharmacokinetic pharmacological pharmacovigilance phase physicians placebo population possible post-marketing prescribing problems protocol questionnaire questions reference interval regulations regulatory authorities relevant renal Research response risk safety data scale side effects specific spontaneous reports standard statistical studies survey symptoms syndrome therapeutic therapy tion toxicity treatment trialist type A reactions volunteers warfarin weeks
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