title: A statistical methodology for postmarketing surveillance of adverse drug reaction reports.
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.
authors.affiliation: Ortho Pharmaceutical Corporation, Pittsburgh, PA.
authors.forename: P K
authors.initials: PK
authors.lastname: Norwood
authors.forename: A R
authors.initials: AR
authors.lastname: Sampson
mesh_terms: D003198:Computer Simulation; D004304:Dosage Forms; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015233:Models, Statistical; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012984:Software
chemical_list: D004304:Dosage Forms