Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells

Xilin Li(National Center for Toxicological Research), Nan Mei(Jilin Agricultural University), Aisar Atrakchi(Center for Drug Evaluation and Research), Robert T. Dorsam(United States Food and Drug Administration), Yuan Le(National Center for Toxicological Research), Robert H. Heflich(National Center for Toxicological Research), Timothy J. McGovern(Center for Drug Evaluation and Research), Karen Davis‐Bruno(United States Food and Drug Administration), Sruthi Tallapragada King(United States Food and Drug Administration), Xiaoqing Guo(National Center for Toxicological Research), David A. Keire(Center for Drug Evaluation and Research)
Regulatory Toxicology and Pharmacology
October 20, 2024
Cited by 17


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