The in vitro alkaline comet assay with liver models as a complementary tool for genotoxicity assessment of N-nitrosamines
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N-nitrosamine (NA) impurities in pharmaceuticals represent "cohort of concern" compounds under ICH M7(R2), due to their mutagenic/carcinogenic potential, involving cytochrome P450 (CYP)-mediated metabolic activation. Increasing interest in mammalian cell-bas... ...
