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 data.

doi:10.1016/j.yrtph.2026.106051

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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 data.

Regulatory toxicology and pharmacology : RTP - 1 May 2026

Jolly Robert A, Trejo-Martin Alejandra, Bercu Joel P, Powley Mark W, Tennant Rachael E, Ponting David J, Nudelman Raphael, Sobol Zhanna, Czich Andreas, Johnson George E, Yang Yi, Kobets Tetyana, White Paul A, Minocherhomji Sheroy, Lynch Anthony M, Zeller Andreas, Ott Gregory R, Escobar Patricia A, Hobbs Cheryl, Schuler Maik, Chen Connie L, Puglisi Raechel

Abstract excerpt

Nitrosamines (NAs) are a diverse class of mutagenic impurities encompassing both small molecules and structurally complex drug-related NAs, referred to as nitrosamine drug substance-related impurities (NDSRIs). NAs display a broad range of carcinogenic potential, from high carcinogenic potency to being weak or even non-carcinogenic. In vitro Ames tests, conducted with both rat and hamster liver-induced S9, and in...

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PMID: 41621793
DOI: 10.1016/j.yrtph.2026.106051

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