ICH S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals

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Regulatory notice

Reference numberEMA/CHMP/ICH/536328/2013 Rev. 1
Published02/03/2016
KeywordsRodent carcinogenicity testing, animal testing
DescriptionThis document concerns the need for a change to current  ICH S1 guidance on rodent carcinogenicity testing. The potential change intends to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals. It also aims to define conditions under which 2-year rat carcinogenicity studies add value to that assessment.


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