Pharma Investments, Ventures & Law Weekly
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Adverse Drug Reactions
Investigators at University of Copenhagen zero in on adverse drug reactions
April 27th, 2008
"Spontaneous reports of adverse drug reactions (ADRs) are often the only documentation used to justify the recall of drugs from the market. The purpose of this study was to investigate whether it would have been possible to foresee serious ADR cases based on available information on ADRs reported in Phase II and III clinical trials before marketing," scientists writing in the British Journal of Clinical Pharmacology report. "We conducted a retrospective analysis of reported ADR data in Phase II/III clinical trials in the registration material for three different ADR scenarios: (i) trovafloxacin/alatrofloxacin and hepatotoxicity; (ii) tolcapone and hepatotoxicity...
Source: Pharma Investments, Ventures & Law Weekly (2008-04-27)
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