Non-clinical evaluation of drug-induced liver injury (DILI) - Scientific guideline

This document reviews current approaches to the detection of drug-induced hepatotoxicity alerts in non-clinical, regulatory toxicity studies. It aims to provide an overview and guidance to facilitate further discussions on this topic.

Keywords: Aminotransferase, cholestasis, mitochondrial toxicity, hepatocytes, hepatotoxicity, steatosis

Current version

Reflection paper on non-clinical evaluation of drug-induced liver injury (DILI)

AdoptedReference Number: EMEA/CHMP/SWP/150115/2006

Document history - First version (current)

Reflection paper on non-clinical evaluation of drug-induced liver injury (DILI)

AdoptedReference Number: EMEA/CHMP/SWP/150115/2006

Draft non-clinical guideline on drug-induced hepatotoxicity

Consultation dates: 24/01/2008 to 30/08/2008Draft: consultation closedReference Number: EMEA/CHMP/SWP/150115/2006