Postmarketing Adverse Drug Event Signaling

Authored by: Yi Tsong

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-130001165

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Abstract

Postmarket adverse drug reaction (ADR) surveillance is designed exactly for the purpose of identifying the low-frequency reactions that are not caught in pre-marketing studies, the high-risk group, drug–drug interaction, the longterm effect of the drug, and the increased severity and/or frequency of known reactions. This entry provides statistical analysis methods for identifying these reactions in a drug.

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