Not logged in Mutagenicity of N-nitroso-fluoxetine and N-nitroso-varenicline in human HepaRG cell models Seo, Ji-Eun; Xu, Hannah S.; Revollo, Javier R.; Miranda-Colon, Jaime A.; Atrakchi, Aisar H.; McGovern, Timothy J.; Davis Bruno, Karen L.; Keire, David A.; Heflich, Robert H.; Guo, Xiaoqing Share Save
Nitrosamine Ames Data Review and Method Development: proceedings of a US FDA/HESI workshop Atrakchi, Aisar; Puglisi, Raechel; Bercu, Joel; Cheung, Jennifer; Czich, Andreas; Froestchl, Roland; Davis-Bruno, Karen; Heflich, Robert H.; Kobets, Tetyana; McGovern, Timothy J.; Lynch, Anthony; Selby, Max; Schuler, Maik; Silveira, Gabriela De Oliveira; Vespa, Alisa; Whomsley, Rhys; Chen, Connie L. Share Save
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HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions Bercu, Joel; Trejo-Martin, Alejandra; Chen, Connie; Schuler, Maik; Cheung, Jennifer; Cheairs, Tetyana; Lynch, Anthony M.; Thomas, Dean; Czich, Andreas; Atrakchi, Aisar; Mcgovern, Timothy J.; Heflich, Robert H.; Vespa, Alisa; Froetschl, Roland; Yang, Yi; Gandhi, Raj D.; Elloway, Joanne; Ziegler, Verena; Hellmann, Anna; Schaefer, Michelle; Tennant, Rachael E.; Westerink, Walter; Hoffmans, Roy; Jolly, Robert; Noteboom, Jessica; Gollapudi, Pavan; Sobol, Zhanna; Mcgettigan, Katherine K.; Christensen, Joel S.; Simon, Stephanie; Dieckhoff, Jessica; Zeller, Andreas; Marchand, Christine; Waese, Kerstin; Bishop, Michelle E.; Leavitt, Penny; Hargreaves, Victoria; Glick, Connor; Liao, Yang; Elespuru, Rosalie; Puglisi, Raechel Share Save
Integration of the rat liver micronucleus assay into a 28-day treatment protocol: testing the genotoxicity of 4 small-molecule nitrosamines with different carcinogenic potencies and tumor target specificities Guo, Xiaoqing; Seo, Ji-Eun; Xu, Hannah; Yan, Jian; Malhi, Pritpal; Atrakchi, Aisar H.; Mcgovern, Timothy; Bruno, Karen L. Davis; Heflich, Robert H.; Chen, Tao Share Save
Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells Li, Xilin; Le, Yuan; Guo, Xiaoqing; King, Sruthi T.; Dorsam, Robert T.; Atrakchi, Aisar H.; McGovern, Timothy J.; Davis-Bruno, Karen L.; Keire, David A.; Heflich, Robert H.; Mei, Nan Share Save
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test☆ Heflich, Robert H.; Bishop, Michelle E.; Mittelstaedt, Roberta A.; Yan, Jian; Guerrero, Sharon K.; Sims, Audrey M.; Mitchell, Kamela; Moore, Nyosha; Li, Xilin; Mei, Nan; Elespuru, Rosalie K.; King, Sruthi T.; Keire, David A.; Kruhlak, Naomi L.; Dorsam, Robert T.; Raw, Andre S.; Bruno, Karen L. Davis; McGovern, Timothy J.; Atrakchi, Aisar H. Share Save
Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA) Kruhlak, Naomi L.; Schmidt, Marianne; Froetschl, Roland; Graber, Stefan; Haas, Bodo; Horne, Irene; Horne, Stephen; King, Sruthi T.; Koval, Iryna A.; Kumaran, Govindaraj; Langenkamp, Anja; McGovern, Timothy J.; Peryea, Tyler; Ferreira, Aline Siqueira; Sanh, Alan; van Aerts, Leon; Vespa, Alisa; Whomsley, Rhys Share Save
ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup Bourcier, Todd; McGovern, Timothy; Cavaliero, Tania; Ebere, Geoffrey; Nishikawa, Akiyoshi; Nishimura, Jihei; Ogawa, Kumiko; Pasanen, Markku; Vespa, Alisa; Van der Laan, Jan Willem Share Save
Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models Seo, Ji-Eun; Yu, Joshua Z.; Xu, Hannah; Li, Xilin; Atrakchi, Aisar H.; McGovern, Timothy J.; Bruno, Karen L. Davis; Mei, Nan; Heflich, Robert H.; Guo, Xiaoqing Share Save
Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays Li, Xilin; Le, Yuan; Seo, Ji-Eun; Guo, Xiaoqing; Li, Yuxi; Chen, Si; Mittelstaedt, Roberta A.; Moore, Nyosha; Guerrero, Sharon; Sims, Audrey; King, Sruthi T.; Atrakchi, Aisar H.; Mcgovern, Timothy J.; Davis-Bruno, Karen L.; Keire, David A.; Elespuru, Rosalie K.; Heflich, Robert H.; Mei, Nan Share Save
Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s Li, Xilin; He, Xiaobo; Le, Yuan; Guo, Xiaoqing; Bryant, Matthew S.; Atrakchi, Aisar H.; McGovern, Timothy J.; Davis-Bruno, Karen L.; Keire, David A.; Heflich, Robert H.; Mei, Nan Share Save
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