Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions.

We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripipraz...

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Bibliographic Details
Main Authors: Masayuki Hashiguchi, Shungo Imai, Keiko Uehara, Junya Maruyama, Mikiko Shimizu, Mayumi Mochizuki
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2015-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4671724?pdf=render