Carcinogenicity studies are conducted across multiple timeframes to assess long-term cancer risks associated with drugs. This includes mouse and rat models, as well as specialized assays for cell therapy products.
Tests:
-2-year carcinogenic test in rats
-18-24 month mouse carcinogen test
-6-month carcinogenic assay in rasH 2 transgenic mice
-Oncogenic tests for cell therapy products (in vivo and in vitro)
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