Accelerating NDA filing through faster carcinogenicity assessment
Drug Discovery World
MAY 10, 2023
Carcinogenicity testing For decades, the two-year rodent bioassay has been the regulatory standard used to determine the carcinogenic potential of new drugs. This process historically involved lifetime carcinogenicity bioassays in two species. Figure 1: Comparing Carcinogenicity Testing Timelines in Transgenic vs. Standard Mice.
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