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Value of preapproval safety data in predicting postapproval hepatic safety and assessing the legitimacy of class warning

Objective: The objective of this study was to systematically evaluate whether preapproval safety data for nonhepatotoxic drugs and hepatotoxic drugs can be compared to improve preapproval prediction of postapproval hepatic safety and to assess the legitimacy of applying class warnings. Methods: Drug...

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Detalhes bibliográficos
Main Authors: Lin, Yeong-Liang, Wu, Ya-Chi, Gau, Churn-Shiouh, Lin, Min-Shung
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4110826/
https://ncbi.nlm.nih.gov/pubmed/25083222
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2042098611425183
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