A statistical methodology for postmarketing surveillance of adverse drug reaction reports
- 1 October 1988
- journal article
- research article
- Published by Wiley in Statistics in Medicine
- Vol. 7 (10) , 1023-1030
- https://doi.org/10.1002/sim.4780071004
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.Keywords
This publication has 1 reference indexed in Scilit:
- Testing Statistical HypothesesPublished by Springer Nature ,1986