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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer International Publishing
2014
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212149/ https://www.ncbi.nlm.nih.gov/pubmed/25352328 http://dx.doi.org/10.1007/s40264-014-0186-3 |