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Liver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials

A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in c...

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Detalhes bibliográficos
Main Authors: Avigan, Mark I., Bjornsson, Einar S., Pasanen, Markku, Cooper, Charles, Andrade, Raul J., Watkins, Paul B., Lewis, James H., Merz, Michael
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4212151/
https://ncbi.nlm.nih.gov/pubmed/25352325
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40264-014-0183-6
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