N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 DaJoel P. Bercu, Mike W Urquhart, Michelle Kenyon et al.|Regulatory Toxicology and Pharmacology|2024Cited by 14
Ames concordance with the in vivo transgenic rodent (TGR) gene mutation assay for NDSRIs and relative in vivo TGR potency with nitrosamines with robust dose-response carcinogenicity dataRobert A. Jolly, Raechel Puglisi, Alejandra Trejo-Martin et al.|Regulatory Toxicology and Pharmacology|2026Cited by 3