Is the two-year rodent bioassay really necessary determine the tumorigenic potential of novel pharmaceuticals?Despite forty years as the regulatory standard in carcinogenicity testing, recent analyses of multiple carcinogenicity datasets indicate that the lifetime bioassay may not be the best tool for carcinogenicity risk assessment. Proposed changes to the ICH S1 guidelines could transform the assessment process, dramatically accelerating development and approval.
What does this mean for your drug development and risk assessment pipeline?
Faster, More Accurate Carcinogenicity Testing
Download this free report to learn how these regulatory changes enable use of more efficient animal models to shorten the evaluation and approval of novel pharmaceutical compounds:- What are the limitations of existing testing protocols?
- How will these new ICH S1 guidelines impact drug development?
- How can the rasH2 transgenic mouse model facilitate more efficient and accurate carcinogenicity testing under these new guidelines?
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