Search Results - "Rich, Donna S"
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Effect of consumer reporting on signal detection: using disproportionality analysis
Published in Expert opinion on drug safety (01-11-2007)“…Pharmacovigilance objectives and activities are designed to protect the health of consumers and are generally based on data acquisition from spontaneous…”
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Database size and power to detect safety signals in pharmacovigilance
Published in Expert opinion on drug safety (01-11-2007)“…Most regulatory agencies and pharmaceutical companies focus the majority of their pharmacovigilance on safety signal identification in large databases…”
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The evaluation of drug rechallenge: The casopitant Phase III program
Published in Regulatory toxicology and pharmacology (01-12-2010)“…Drug rechallenge (or reinitiation), following an event of drug-induced liver injury, is associated with 13% mortality in prospective series. Rechallenge…”
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