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Methodological considerations for comparison of brand versus generic versus authorized generic adverse event reports in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS)

BACKGROUND: The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand vs. generic safety signals. OBJECTIVE: To explore the methods for identifying and analyzing brand vs. generic adverse event (AE) reports. MET...

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Bibliografiske detaljer
Udgivet i:Clin Drug Investig
Main Authors: Rahman, Md. Motiur, Alatawi, Yasser, Cheng, Ning, Qian, Jingjing, Peissig, Peggy L., Berg, Richard L., Page, David C., Hansen, Richard A.
Format: Artigo
Sprog:Inglês
Udgivet: 2017
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC5842081/
https://ncbi.nlm.nih.gov/pubmed/28933038
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40261-017-0574-4
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