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A statistical methodology for postmarketing surveillance of adverse drug reaction reports
Author(s) -
Norwood Paula K.,
Sampson Allan R.
Publication year - 1988
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780071004
Subject(s) - postmarketing surveillance , drug reaction , drug , adverse drug reaction , computer science , medicine , adverse effect , pharmacology
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.