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Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines

Trejo-Martin A; Bercu JP; Thresher A; Tennant RE; Thomas RF; Cross K; Czich A; Waese K; Nicolette JJ; Murray J; Sonders P; Kondratiuk A; Cheung JR; Thomas D; Lynch A; Harvey J; Glowienke S; Custer LL; Escobar PA;

Under ICH M7, impurities are assessed using the bacterial reverse mutation assay (i.e., Ames test) when predicted positive using in silico methodologies followed by expert review. N-Nitrosamines (NAs) have been of recent concern as impurities in pharmaceuticals, mainly because of their potential to be highly potent mutagenic carcinogens in rodent bioassays. The purpose of this analysis was to determine the sensitivity of the Ames assay to predict the carcinogenic outcome with curated proprietary Vitic (n = 131) and Leadscope (n = 70) databases. NAs were selected if they had corresponding rodent carcinogenicity assays.

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