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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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| Veröffentlicht in: | CPT Pharmacometrics Syst Pharmacol |
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| Hauptverfasser: | , , , , , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
John Wiley and Sons Inc.
2018
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| Schlagworte: | |
| 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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