GDUFA Research Outcomes

Nitrosamines

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to impurities such as nitrosamine drug substance related impurities (NDSRIs) that may arise in drug products, including generic products.

• All(41)
• Posters(0)
• Presentations(24)
• Papers(17)

• N-Nitroso-Ethylisopropylamine Mutagenicity in Rat Liver Using the cII Transgenic Mutation Assay and Duplex Sequencing Analysis of Genomic DNA

  Xia, Li; Yan, Jian; Chen, Ying; Mitchell, Kamela; McGovern, Timothy J; Atrakchi, Aisar H; Heflich, Robert H; Chen, Tao

• Genotoxicity Evaluation of Ten Nitrosamine Drug Substance-Related Impurities Using 2D and 3D HepaRG Cell Models

  Seo, Ji-Eun; Xu, Hannah; Li, Xilin; Atrakchi, Aisar H; McGovern, Timothy; Davis Bruno, Karen L; Keire, David A; Mei, Nan; Heflich, Robert H; Guo, Xiaoqing

• 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; Gollapundi, Pavan; Sobol, Zhanna; McGettigan, Katherine K; Christensen, Joel S; Simon, Stephanie; Dieckhoff, Jessica; Zeller, Andreas; Marchand, Christine; Waesse, Kerstin; Bishop, Michelle E; Leavitt, Penny; Hargreaves, Victoria; Glick, Connor; Liao, Yang; Elespuru, Rosalie; Puglisi, Raechel

• Integration of the Rat Liver Micronucleus Assay Into a 28-Day Treatment Protocol: Testing the Genotoxicity of Four 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; Davis Bruno, Karen L; Heflich, Robert H; Chen, Tao

• Development of a TK6-Derived Cell Line Expressing Four Human Cytochrome P450s for Genotoxicity Testing

  Li, Xilin; Wang, Yuhan; Xu, Hannah; He, Xiaobo; Chen, Si; Guo, Xiaoqing; Manjanatha, Mugimane G; Zhou, Tong; Bonzo, Jessica; Mei, Nan

• Comparative DNA Damage Induced by Eight Nitrosamines in Primary Human and Macaque Hepatocytes

  Seo, Ji-Eun; He, Xiaobo; Bryant, Matthew; Atrakchi, Aisar H; McGovern, Timothy J; Davis Bruno, Karen L; Heflich, Robert H; Guo, Xiaoqing

• Nitrosamine-Impacted Drug Products Containing BCS IV Drug Substances

  Zhao, Gang

• Application of HepaRG Cells for Genetic Toxicity Testing

  Seo, Ji-Eun

• Genotoxicity Assessment of Eight Nitrosamines using 2D and 3D HepaRG Cell Models

  Seo, Ji-Eun; Yu, Joshua Z; Xu, Hannah; Li, Xilin; Atrakchi, Aisar; Mcgovern, Timothy; Bruno, KLD; Mei, Nan; Heflich, RH; Guo, Xiaoqing

• Analytical Procedure Development and Proposed Established Conditions: A Case Study of a Mass Spectrometry Based NDSRI Analytical Procedure

  Zhang, Jinhui; Raghavachari, Ramesh; Kirkpatrick, Douglas; Keire, David A; Xu, Xiaoming; Faustino, Patrick J