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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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Dades bibliogràfiques
Publicat a:Drug Saf
Autors principals: 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
Format: Artigo
Idioma:Inglês
Publicat: Springer International Publishing 2021
Matèries:
Accés en línia: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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