CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment - Scientific guideline
HumanScientific guidelines
This document discusses regulatory acceptance of the use of transgenic animal models for carcinogeniciy testing. It provides an assessment of the data generated by ILSI/HESI Alternatives to Caricongenicity Testing Project.
Keywords: Carcinogenicity, genetically modified animal models, transgenic model, knockout model, ILSI/HESI study