On September 2013 the ICH S1 expert working group released a regulatory notice on the necessity of carcinogenicity testing in rodents for small molecule pharmaceuticals with ongoing or planned carcinogenicity testing. Sponsors of pharmaceuticals will be strongly encouraged to provide a Carcinogenicity Assessment Document (CAD) to Drug Regulatory Agencies which could justify a 'waiver request' that seeks to omit the conduct of 2-years rat carcinogenicity study.
The CAD should address the overall carcinogenic risk of the investigational drug as predicted by specific endpoints (pharmacological targets and pathways, toxicological data and other sources) and a rationale for why the conduct of 2-years carcinogenicity studies in vivo would or would not add value to that assessment. The aim is to justify proceedings with revision of the ICH S1 guidance.
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