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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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Detalles Bibliográficos
Autores principales: 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: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184702/
https://www.ncbi.nlm.nih.gov/pubmed/33725335
http://dx.doi.org/10.1007/s40264-021-01051-5