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A statistical methodology for postmarketing surveillance of adverse drug reaction reports
1Ortho Pharmaceutical Corporation, Pittsburgh, PA.
Statistics in Medicine
|October 1, 1988
Abstract:
This paper presents a statistically optimal exact hypothesis testing procedure for detecting changes in sales adjusted adverse drug reaction (ADR) rates between historical and current periods, with a computer program that implements this test appended. We provide discussions and illustrations on how to monitor ADR rates for product lines that consist of several pharmacologically equivalent dosage forms.