AMES Test Study Designs for Nitrosamine Mutagenicity Testing -Pub

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For extra data on the case of N-nitroso-dabigatran: see SOT 2024 poster presented by FDA scientists:

SOT posters and talks, (shared posters -update)

A big shot out to our FDA colleagues who have been kind to share the posters from the recent SOT … Xiaoqing Guo: In vitro mutagenicity assessment of N-nitrosodimethylamine in 2D and 3D HepaRGcell cultures using High-Fidelity sequencing [image] 2024 SOT Carol NDMA HiFi.pdf (758.1 KB) Xilin Li (DGMT). “Mutagenicity and Genotoxicity of Twelve Nitrosamine Drug Substance-Related Impurities in Human TK6 Cells: Correlation with Enhanced Ames Test” [image] SOT2024 upload.pdf (621.3 KB)