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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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Dettagli Bibliografici
Pubblicato in:CPT Pharmacometrics Syst Pharmacol
Autori principali: Schotland, Peter, Racz, Rebecca, Jackson, David, Levin, Robert, Strauss, David G., Burkhart, Keith
Natura: Artigo
Lingua:Inglês
Pubblicazione: John Wiley and Sons Inc. 2018
Soggetti:
Accesso online: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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