Target‐Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

Clinical trials can fail to detect rare adverse events (AEs). We assessed the ability of pharmacological target adverse‐event (TAE) profiles to predict AEs on US Food and Drug Administration (FDA) drug labels at least 4 years after approval. TAE profiles were generated by aggregating AEs from the FD...

Disgrifiad llawn

Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:CPT Pharmacometrics Syst Pharmacol
Prif Awduron: Schotland, Peter, Racz, Rebecca, Jackson, David, Levin, Robert, Strauss, David G., Burkhart, Keith
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: John Wiley and Sons Inc. 2018
Pynciau:
Research
Mynediad Ar-lein:https://ncbi.nlm.nih.gov/pmc/articles/PMC6310867/
https://ncbi.nlm.nih.gov/pubmed/30354029
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/psp4.12356
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