Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials

Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs), developed this manuscript with the following obje...

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Detalhes bibliográficos
Publicado no:Drug Saf
Main Authors: Hey-Hadavi, Juliana, Seekins, Daniel, Palmer, Melissa, Coffey, Denise, Caminis, John, Abdullaev, Sandzhar, Patwardhan, Meenal, Tyler, Haifa, Raheja, Ritu, Stanley, Ann Marie, Pineda-Salgado, Liliam, Bourdet, David L., Andrade, Raul J., Hayashi, Paul H., Dimick-Santos, Lara, Rockey, Don C., Estilo, Alvin
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2021
Assuntos:
Leading Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8184702/
https://ncbi.nlm.nih.gov/pubmed/33725335
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40264-021-01051-5
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