Characteristics of drugs safety signals that predict safety related product information update

PURPOSE: Investigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signa...

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Bibliographic Details
Published in:Pharmacoepidemiol Drug Saf
Main Authors: Insani, Widya N., Pacurariu, Alexandra C., Mantel‐Teeuwisse, Aukje K., Gross‐Martirosyan, Liana
Format: Artigo
Language:Inglês
Published: John Wiley and Sons Inc. 2018
Subjects:
Original Reports
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC6055643/
https://ncbi.nlm.nih.gov/pubmed/29797381
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pds.4446
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