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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Legal Aspects of Pharmacovigilance
Ethics Honesty and the Pharmaceutical Industry
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abnormal ADRs Adverse Drug Reactions adverse event adverse reactions analysis aplastic anaemia assessment baseline beta blockers bilirubin causality cause centres changes chlorpromazine CIOMS clinical trials COSTART CPMP creatinine data sheet database dechallenge detect digoxin disease doctor dose Drug Safety Drug-induced epidemiological ethical evaluation factors guidelines Guillain-Barré syndrome hepatic hospital incidence increase individual International investigations investigator's brochure laboratory data liver marketing measure 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 Spriet standard statistical studies survey symptoms syndrome therapeutic therapy tion toxicity treatment trialist type A reactions vaccine volunteers warfarin weeks
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