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Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges
Prompted by approval in 1997 of troglitazone and bromfenac, two drugs that promptly began to show serious and sometimes fatal liver toxicity, we began at the Food and Drug Administration (FDA) a series of annual conferences in 1999 to consider issues of drug-induced liver injury (DILI). First inviti...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2014
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212154/ https://www.ncbi.nlm.nih.gov/pubmed/25352324 http://dx.doi.org/10.1007/s40264-014-0182-7 |