Publications by authors named "Robert Heflich"

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Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models.
Ji-Eun Seo, Hannah Xu, Xilin Li, Aisar H Atrakchi, Timothy McGovern, Robert H Heflich

Regul Toxicol Pharmacol· November 2025

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Mutation accumulation following extended exposure of human HepaRG cells to a genotoxic carcinogen.
Xiaoqing Guo, Ji-Eun Seo, Jaime Miranda-Colon, Hannah Xu, Javier Revollo, Robert H Heflich

J Environ Sci Health C Toxicol Carcinog· November 2025

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Detection of In Vivo Mutation in the Hprt and Pig-a Genes of Rat Lymphocytes.
Vasily N Dobrovolsky, Joseph G Shaddock, Roberta A Mittelstaedt, Daishiro Miura, Robert H Heflich

Methods Mol Biol· November 2025

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Assessing carcinogenic outcomes following short-term exposure to potentially DNA-reactive drugs: Are available data sufficient to inform risk assessment?
Dayton M Petibone, Jennifer M Shemansky, Timothy W Robison, Aisar H Atrakchi, Robert H Heflich

Regul Toxicol Pharmacol· November 2025

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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.
Joel Bercu, Alejandra Trejo-Martin, Connie Chen, Maik Schuler, Jennifer Cheung, Robert H Heflich

Regul Toxicol Pharmacol· September 2025

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N-nitroso-ethylisopropylamine mutagenicity in rat liver using the cII transgenic mutation assay and duplex sequencing analysis of genomic DNA.
Li Xia, Jian Yan, Ying Chen, Kamela Mitchell, Timothy J McGovern, Robert H Heflich

Chem Biol Interact· September 2025

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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.
Xiaoqing Guo, Ji-Eun Seo, Hannah Xu, Jian Yan, Pritpal Malhi, Robert H Heflich

Toxicol Sci· August 2025

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Comparative DNA damage induced by eight nitrosamines in primary human and macaque hepatocytes.
Ji-Eun Seo, Xiaobo He, Matthew Bryant, Aisar H Atrakchi, Timothy J McGovern, Robert H Heflich

Chem Biol Interact· August 2025

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Characterizing the Pulmonary Toxicity and Potential Mutagenicity of Formaldehyde Fumes in a Human Bronchial Epithelial Tissue Model.
Yuan Le, Baiping Ren, Levan Muskhelishvili, Kelly Davis, Yiying Wang, Robert H Heflich

Environ Mol Mutagen· May 2025

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Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells.
Xilin Li, Yuan Le, Xiaoqing Guo, Sruthi T King, Robert T Dorsam, Robert H Heflich

Regul Toxicol Pharmacol· December 2024

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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test.
Robert H Heflich, Michelle E Bishop, Roberta A Mittelstaedt, Jian Yan, Sharon K Guerrero

Regul Toxicol Pharmacol· November 2024

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Repeat treatment of organotypic airway cultures with ethyl methanesulfonate causes accumulation of somatic cell mutations without expansion of bronchial-carcinoma-specific cancer driver mutations.
Yiying Wang, Yuan Le, Kelly L Harris, Ying Chen, Xilin Li, Robert H Heflich

Mutat Res Genet Toxicol Environ Mutagen· July 2024

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Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing.
Ji-Eun Seo, Yuan Le, Javier Revollo, Jaime Miranda-Colon, Hannah Xu, Robert H Heflich

Arch Toxicol· June 2024

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Severity of effect considerations regarding the use of mutation as a toxicological endpoint for risk assessment: A report from the 8th International Workshop on Genotoxicity Testing (IWGT).
Barbara L Parsons, Marc A Beal, Kerry L Dearfield, George R Douglas, Min Gi, Robert H Heflich

Environ Mol Mutagen· June 2024

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Erythrocyte PIG-A mutant frequencies in cancer patients receiving cisplatin.
Vasily N Dobrovolsky, Omar T Atiq, Robert H Heflich, Mackean Maisha, Page B McKinzie

Cancer Med· February 2024

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Error-corrected next generation sequencing - Promises and challenges for genotoxicity and cancer risk assessment.
Francesco Marchetti, Renato Cardoso, Connie L Chen, George R Douglas, Joanne Elloway, Robert H Heflich

Mutat Res Rev Mutat Res· December 2023

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Interpretation of in vitro concentration-response data for risk assessment and regulatory decision-making: Report from the 2022 IWGT quantitative analysis expert working group meeting.
Marc A Beal, Guangchao Chen, Kerry L Dearfield, Min Gi, Bhaskar Gollapudi, Robert H Heflich

Environ Mol Mutagen· December 2023

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Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models.
Ji-Eun Seo, Joshua Z Yu, Hannah Xu, Xilin Li, Aisar H Atrakchi, Robert H Heflich

Arch Toxicol· October 2023

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Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays.
Xilin Li, Yuan Le, Ji-Eun Seo, Xiaoqing Guo, Yuxi Li, Robert H Heflich

Regul Toxicol Pharmacol· June 2023

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Assessing the quality and making appropriate use of historical negative control data: A report of the International Workshop on Genotoxicity Testing (IWGT).
Stephen D Dertinger, Dingzhou Li, Carol Beevers, George R Douglas, Robert H Heflich

Environ Mol Mutagen· April 2023

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Error-corrected next-generation sequencing to advance nonclinical genotoxicity and carcinogenicity testing.
Francesco Marchetti, Renato Cardoso, Connie L Chen, George R Douglas, Joanne Elloway, Robert H Heflich

Nat Rev Drug Discov· March 2023

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Key Challenges and Recommendations for Testing of Tobacco Products for Regulatory Applications: Consideration of Test Materials and Exposure Parameters.
Martha M Moore, Irene Abraham, Mark Ballantyne, Holger Behrsing, Xuefei Cao, Robert H Heflich

Altern Lab Anim· January 2023

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Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s.
Xilin Li, Xiaobo He, Yuan Le, Xiaoqing Guo, Matthew S Bryant, Robert H Heflich

Arch Toxicol· November 2022

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90-day nose-only inhalation toxicity study of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Sprague-Dawley rats.
Shu-Chieh Hu, Seonggi Min, Hyun-Ki Kang, Dong-Jin Yang, Mallikarjuna Basavarajappa, Robert H Heflich

Food Chem Toxicol· February 2022

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Effect of life stage and target tissue on dose-response assessment of ethyl methane sulfonate-induced genotoxicity.
Roberta A Mittelstaedt, Azra Dad, Mason G Pearce, Robert H Heflich, Xuefei Cao

Environ Mol Mutagen· November 2021

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