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

2026/01/30 by Robert A. Jolly, Alejandra Trejo-Martin, Joel P. Bercu +23 · 1 voice
Biochemistry, Genetics and Molecular Biology · Environmental Science · #Ames test #Bioassay #Carcinogen #Carcinogens and Genotoxicity Assessment #Hamster #In vitro #In vivo #Nitrosamine #Polyamine Metabolism and Applications #Potency #Water Treatment and Disinfection

paper · doi:10.1016/j.yrtph.2026.106051

openalex publication_date 2026/01/30 · crossref created 2026/01/30 · openalex created_date 2026/02/01 · crossref deposited 2026/03/03 · crossref indexed 2026/04/15 · crossref issued 2026/05/01 · crossref published 2026/05/01 · crossref published-print 2026/05/01 · openalex updated_date 2026/08/06

Citations

• Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
• Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)
• Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)

Discussions

• HESI Global GTTC published new evidence to improve nitrosamine (NDSRI) risk evaluation: 79% concordance between Ames & TGR across 33 NDSRIs, supporting stronger science-based decisions that protect pa [bsky, 0 points, 0 comments]