R
Robert H. Heflich Data-verified
Affiliation confirmed via AI analysis of OpenAlex, ORCID, and web sources.
High Impact
Researcher
faculty
52 h-index
295 pubs
8,730 cited
Research Areas
Links
Biography and Research Information
OverviewAI-generated summary
Robert H. Heflich's research focuses on evaluating the mutagenicity and genotoxicity of various chemical compounds, particularly nitrosamines and impurities found in pharmaceuticals. His work utilizes advanced molecular biology techniques, including error-corrected next-generation sequencing and human in vitro cell models such as TK6 cells and HepaRG cell cultures (both 2D and 3D). He investigates DNA damage and mutagenesis, often employing methods like the CometChip and Duplex Sequencing to assess genetic toxicity.
Heflich has published extensively on these topics, with recent work exploring the application of error-corrected next-generation sequencing to improve genotoxicity and carcinogenicity testing. His research also involves assessing the genotoxicity of nitrosamine impurities, optimizing detection methods in standard assays like the Ames test, and evaluating mutagenicity in various human cell culture systems, including organotypic airway cultures.
His research group collaborates with several colleagues at the National Center for Toxicological Research, including Nan Mei, Roberta A. Mittelstaedt, Yuan Le, and Ji‐Eun Seo. Heflich is recognized as a highly cited researcher, with an h-index of 52 and over 8,600 citations across his 291 publications.
Metrics
- h-index: 52
- Publications: 295
- Citations: 8,730
Selected Publications
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Adjusting the Preincubation Conditions to Enhance the Ames Test for Detecting the Mutagenicity of <i>N</i> ‐Nitrosamines (2026)
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Mutagenicity of EAT-positive NDSRIs in HepaRG spheroids (2026)
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Comparative genotoxicity assessment of ortho-phthalaldehyde using human in vitro organotypic airway epithelial cultures and standard in vitro genotoxicity assays (2026)
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Mutagenicity of <i>N</i> -nitroso-fluoxetine and <i>N</i> -nitroso-varenicline in human HepaRG cell models (2026)
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Nitrosamine Ames Data Review and Method Development: proceedings of a US FDA/HESI workshop (2026)
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Detection of In Vivo Mutation in the Hprt and Pig-a Genes of Rat Lymphocytes (2025)
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Mutation accumulation following extended exposure of human HepaRG cells to a genotoxic carcinogen (2025)
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Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models (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 (2025)
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Comparative DNA damage induced by eight nitrosamines in primary human and macaque hepatocytes (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 (2025)
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Characterizing the Pulmonary Toxicity and Potential Mutagenicity of Formaldehyde Fumes in a Human Bronchial Epithelial Tissue Model (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 (2025)
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Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells (2024)
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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test (2024)
Collaboration Network
Top Collaborators
Aisar Atrakchi
Center for Drug Evaluation and Research (US)
11 shared publications
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
- Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models
- Appropriate in vivo follow-up assays to an in vitro bacterial reverse mutation (Ames) test positive investigational drug candidate (active pharmaceutical ingredient), drug-related metabolite, or drug-related impurity
Showing 5 of 11 shared publications
Xiaoqing Guo
National Center for Toxicological Research
10 shared publications
In database
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s
- Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models
- Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing
- Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells
Showing 5 of 10 shared publications
Nan Mei
United States Food and Drug Administration
10 shared publications
In database
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
- Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models
- Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing
Showing 5 of 10 shared publications
Timothy J. McGovern
United States Food and Drug Administration (US)
10 shared publications
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
- Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models
- Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells
Showing 5 of 10 shared publications
Roberta A. Mittelstaedt
National Center for Toxicological Research
7 shared publications
In database
- Genetic toxicity testing using human in vitro organotypic airway cultures: Assessing <scp>DNA</scp> damage with the <scp>CometChip</scp> and mutagenesis by Duplex Sequencing
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
- Differentiating between micronucleus dose-responses induced by whole cigarette smoke solutions with Benchmark Dose potency ranking
- Effect of life stage and target tissue on dose–response assessment of ethyl methane sulfonate‐induced genotoxicity
Showing 5 of 7 shared publications
Yuan Le
National Center for Toxicological Research
7 shared publications
In database
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s
- Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing
- Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells
- Repeat treatment of organotypic airway cultures with ethyl methanesulfonate causes accumulation of somatic cell mutations without expansion of bronchial-carcinoma-specific cancer driver mutations
Showing 5 of 7 shared publications
Barbara L. Parsons
United States Food and Drug Administration
6 shared publications
In database
- Error-corrected next generation sequencing – Promises and challenges for genotoxicity and cancer risk assessment
- Error-corrected next-generation sequencing to advance nonclinical genotoxicity and carcinogenicity testing
- Interpretation of in vitro concentration‐response data for risk assessment and regulatory decision‐making: Report from the 2022 <scp>IWGT</scp> quantitative analysis expert working group meeting
- <scp>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</scp> (<scp>IWGT</scp>)
- Interpretation of In Vitro Concentration-Response Data for Risk Assessment and Regulatory Decision-making: Report from 2022 IWGT Quantitative Analysis Expert Working Group Meeting
Showing 5 of 6 shared publications
Ji‐Eun Seo
National Center for Toxicological Research
6 shared publications
In database
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models
- Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing
- Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models
- Comparative DNA damage induced by eight nitrosamines in primary human and macaque hepatocytes
Showing 5 of 6 shared publications
B. Bhaskar Gollapudi
Michigan Molecular Institute (United States) (US)
5 shared publications
- Recommendations for conducting the rodent erythrocyte <i>Pig‐a</i> assay: A report from the <scp>HESI GTTC</scp><i>Pig‐a</i> Workgroup
- Interpretation of in vitro concentration‐response data for risk assessment and regulatory decision‐making: Report from the 2022 <scp>IWGT</scp> quantitative analysis expert working group meeting
- <scp>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</scp> (<scp>IWGT</scp>)
- Interpretation of In Vitro Concentration-Response Data for Risk Assessment and Regulatory Decision-making: Report from 2022 IWGT Quantitative Analysis Expert Working Group Meeting
- Issue Information
Mason G. Pearce
United States Food and Drug Administration
5 shared publications
In database
- 14-Day Nose-Only Inhalation Toxicity and Haber’s Rule Study of NNK in Sprague-Dawley Rats
- 90-day nose-only inhalation toxicity study of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Sprague-Dawley rats
- Effect of life stage and target tissue on dose–response assessment of ethyl methane sulfonate‐induced genotoxicity
- Erythrocyte <i>PIG‐A</i> mutant frequencies in cancer patients receiving cisplatin
- <i>Pig‐a</i> gene mutations in bone marrow granulocytes of procarbazine‐treated <scp>F344</scp> rats
Xuefei Cao
National Center for Toxicological Research
5 shared publications
In database
- Genetic toxicity testing using human in vitro organotypic airway cultures: Assessing <scp>DNA</scp> damage with the <scp>CometChip</scp> and mutagenesis by Duplex Sequencing
- Key Challenges and Recommendations for <i>In Vitro</i> Testing of Tobacco Products for Regulatory Applications: Consideration of Test Materials and Exposure Parameters
- Effect of life stage and target tissue on dose–response assessment of ethyl methane sulfonate‐induced genotoxicity
- Repeat treatment of organotypic airway cultures with ethyl methanesulfonate causes accumulation of somatic cell mutations without expansion of bronchial-carcinoma-specific cancer driver mutations
- Characterizing the Pulmonary Toxicity and Potential Mutagenicity of Formaldehyde Fumes in a Human Bronchial Epithelial Tissue Model
Kelly J. Davis
5 shared publications
- Genetic toxicity testing using human in vitro organotypic airway cultures: Assessing <scp>DNA</scp> damage with the <scp>CometChip</scp> and mutagenesis by Duplex Sequencing
- 14-Day Nose-Only Inhalation Toxicity and Haber’s Rule Study of NNK in Sprague-Dawley Rats
- 90-day nose-only inhalation toxicity study of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Sprague-Dawley rats
- Repeat treatment of organotypic airway cultures with ethyl methanesulfonate causes accumulation of somatic cell mutations without expansion of bronchial-carcinoma-specific cancer driver mutations
- Characterizing the Pulmonary Toxicity and Potential Mutagenicity of Formaldehyde Fumes in a Human Bronchial Epithelial Tissue Model
Timothy W. Robison
Center for Drug Evaluation and Research (US)
5 shared publications
- Genetic toxicity testing using human in vitro organotypic airway cultures: Assessing <scp>DNA</scp> damage with the <scp>CometChip</scp> and mutagenesis by Duplex Sequencing
- Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing
- Appropriate in vivo follow-up assays to an in vitro bacterial reverse mutation (Ames) test positive investigational drug candidate (active pharmaceutical ingredient), drug-related metabolite, or drug-related impurity
- Repeat treatment of organotypic airway cultures with ethyl methanesulfonate causes accumulation of somatic cell mutations without expansion of bronchial-carcinoma-specific cancer driver mutations
- Erythrocyte <i>PIG‐A</i> mutant frequencies in cancer patients receiving cisplatin
David A. Keire
United States Food and Drug Administration (US)
5 shared publications
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
- Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells
- Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models
Karen L Davis Bruno
Center for Drug Evaluation and Research (US)
5 shared publications
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
- Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models
- Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models
- Comparative DNA damage induced by eight nitrosamines in primary human and macaque hepatocytes
- 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
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