Robert H. Heflich
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Researcher
Also affiliated: Pacific Northwest Diabetes Research Institute (1980); United States Food and Drug Administration (1985–2026); Letterman Army Medical Center (1973); Thomas Jefferson National Accelerator Facility (2003); Károly Róbert University College (2021); Food and Drug Administration (1985–2019); The Ohio State University (1986); University of Montana (1991); Michigan State University (1977–1980)
Faculty Researcher
Research Areas
Biomedical Subjects
Links
Biography and Research Information
OverviewAI-generated summary
Robert H. Heflich's research focuses on the evaluation of genetic toxicity and mutagenicity, particularly in the context of assessing potential health risks from chemical exposures. He investigates the mechanisms by which substances can damage DNA and induce mutations, employing a range of in vitro and in vivo models. His work utilizes advanced molecular techniques, including error-corrected next-generation sequencing, to enhance the accuracy and sensitivity of genotoxicity testing. This approach aims to improve the assessment of chemical safety for regulatory purposes and public health.
Heflich's recent publications demonstrate a commitment to refining and applying genotoxicity assays. He has explored the use of human cell cultures, such as airway epithelial cells and HepaRG cells, to model human exposure scenarios. His research also specifically addresses the mutagenicity of nitrosamine impurities, a critical area for pharmaceutical safety. Collaborations with colleagues at the National Center for Toxicological Research, including Nan Mei, Ji-Eun Seo, Xilin Guo, and Xilin Li, have been central to advancing these investigations, resulting in numerous shared publications. His work is recognized with a high h-index of 52 and over 8,700 citations, reflecting a significant contribution to the field of toxicology and risk assessment.
Metrics
- h-index: 52
- Publications: 295
- Citations: 8,803
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
- 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 14 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 13 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
- 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
- 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
- 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
- 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
- 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
Showing 5 of 7 shared publications
- 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
- Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing
- Mutagenicity of <i>N</i> -nitroso-fluoxetine and <i>N</i> -nitroso-varenicline in human HepaRG cell models
- <i>Pig‐a</i> gene mutations in bone marrow granulocytes of procarbazine‐treated <scp>F344</scp> rats
- Mutation accumulation following extended exposure of human HepaRG cells to a genotoxic carcinogen
- Mutagenicity of EAT-positive NDSRIs in HepaRG spheroids
- 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
- 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
- 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
- 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
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
- 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
- Comparative genotoxicity assessment of ortho-phthalaldehyde using human in vitro organotypic airway epithelial cultures and standard in vitro genotoxicity assays
- Adjusting the Preincubation Conditions to Enhance the Ames Test for Detecting the Mutagenicity of <i>N</i> ‐Nitrosamines
- 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
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