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

HumanScientific guidelines

Swedish is available via eTranslation, the European Commission's machine translation service.

Translate to Swedish | Important information about machine translation

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)

Adopted Reference Number: EMEA/CHMP/SWP/150115/2006

English (EN) (154.83 KB - PDF)

Först publicerad: Senast uppdaterad:
Visa

Document history - First version (current)

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

Adopted Reference Number: EMEA/CHMP/SWP/150115/2006

English (EN) (154.83 KB - PDF)

Först publicerad: Senast uppdaterad:
Visa

Draft non-clinical guideline on drug-induced hepatotoxicity

Draft: consultation closed Consultation dates: to Reference Number: EMEA/CHMP/SWP/150115/2006

English (EN) (87.6 KB - PDF)

Först publicerad: Senast uppdaterad:
Visa

Share this page