Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance.

Inyoung Lee Todd A Lee Stephanie Y CrawfordRyan D KilpatrickGregory Sampang Calip Jeremy D Jokinen

Published in: Expert opinion on drug safety (2020)

Reports of AEs from PSPs had worse signal detection performance compared to non-PSP sources. Pharmacovigilance experts should be mindful when using databases that contain reports from PSPs for signal detection.

Keyphrases

adverse drug
loop mediated isothermal amplification
real time pcr
label free
public health
drug induced
case report
drinking water
electronic health record
big data
deep learning
sensitive detection