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Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug...

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Detaylı Bibliyografya
Yayımlandı:Drugs R D
Yazar: Boudes, Pol F.
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: Springer International Publishing 2017
Konular:
Online Erişim:https://ncbi.nlm.nih.gov/pmc/articles/PMC5427046/
https://ncbi.nlm.nih.gov/pubmed/28160230
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40268-017-0175-y
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