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.
Download this White Paper to learn:
- The background and limitations of existing carcinogenicity testing protocols
- The proposed changes to ICH S1 guidelines and their potential impact
- How the rasH2 transgenic mouse model can facilitate carcinogenicity testing protocols to meet these new proposed guidelines
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