About the White Paper:
For over 40 years, the 2-year rodent bioassay has been the regulatory standard to determine the tumorigenic potential of novel pharmaceuticals.
Recent retrospective analyses of multiple carcinogenicity datasets have indicated that the lifetime (2-year) bioassay does not always provide further value to the carcinogenicity risk assessment.
As a result, changes to the ICH S1 guidelines have been proposed with the potential to transform how pharmaceutical carcinogenicity evaluations are conducted.