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Liver Safety Assessment in Special Populations (Hepatitis B, C, and Oncology Trials)

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver d...

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Detalhes bibliográficos
Main Authors: Kullak-Ublick, Gerd A., Merz, Michael, Griffel, Louis, Kaplowitz, Neil, Watkins, Paul B.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4212149/
https://ncbi.nlm.nih.gov/pubmed/25352328
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40264-014-0186-3
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