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...

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Bibliographische Detailangaben
Veröffentlicht in:CPT Pharmacometrics Syst Pharmacol
Hauptverfasser: Schotland, Peter, Racz, Rebecca, Jackson, David, Levin, Robert, Strauss, David G., Burkhart, Keith
Format: Artigo
Sprache:Inglês
Veröffentlicht: John Wiley and Sons Inc. 2018
Schlagworte:
Research
Online Zugang: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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