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

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Current effective version

Reflection 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

Reflection paper


Draft reflection paper

Published: 19/07/2010


Published: 24/01/2008


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