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

Current effective version

PDF iconReflection paper

Reference numberCHMP/SWP/150115/06
Published19/07/2010
KeywordsAminotransferase, cholestasis, mitochondrial toxicity, hepatocytes, hepatotoxicity, steatosis
DescriptionThis 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.


Document history

First version

Current version

PDF iconReflection paper


PDF iconDraft reflection paper

Published: 19/07/2010


Published: 24/01/2008


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