A systematic assessment of key design and performance characteristics of drug exposure registries requested by the U.S. Food and Drug Administration.

Yanling ZhaoEllen PinnowJacqueline M Major

Published in: Pharmacoepidemiology and drug safety (2018)

This study suggests clear objectives, patient accrual/retention efforts, adequate analysis plans, and interim reports contribute to the performance of drug exposure registries.

Keyphrases

drug administration
adverse drug
case report
drug induced
risk assessment