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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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Vydáno v:CPT Pharmacometrics Syst Pharmacol
Hlavní autoři: Schotland, Peter, Racz, Rebecca, Jackson, David, Levin, Robert, Strauss, David G., Burkhart, Keith
Médium: Artigo
Jazyk:Inglês
Vydáno: John Wiley and Sons Inc. 2018
Témata:
On-line přístup: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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