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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...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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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 |