The Role of rasH2 in an Evolving Pharmaceutical Carcinogenicity Landscape
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
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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