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Robert H. Heflich

U.S. Food and Drug Administration

52H-index
291Paper Count
8.7KCitation Count
Published Papers 39
Publication Date
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells
err2025-07-09
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PREAI
errJi-Eun Seo; Hannah Xu; Xilin Li; Aisar H. Atrakchi; Timothy McGovern; Karen L. Davis Bruno; David A. Keire; Nan Mei; Robert H. Heflich; Xiaoqing Guo
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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
err2025-06-11
err0
errOAAI
errBercu, 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
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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
err2025-01-03
err0
PREAI
errGuo, Xiaoqing; Seo, Ji-Eun; Xu, Hannah; Yan, Jian; Malhi, Pritpal; Atrakchi, Aisar H.; Mcgovern, Timothy; Bruno, Karen L. Davis; Heflich, Robert H.; Chen, Tao
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Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells
err2024-12-01
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PREAI
errLi, 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
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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test☆
err2024-11-01
err5
PREAI
errHeflich, 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.
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Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing
err2024-04-07
err4
errOAAI
errSeo, Ji-Eun; Le, Yuan; Revollo, Javier; Miranda-Colon, Jaime; Xu, Hannah; McKinzie, Page; Mei, Nan; Chen, Tao; Heflich, Robert H.; Zhou, Tong; Robison, Timothy; Bonzo, Jessica A.; Guo, Xiaoqing
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Genotoxicity assessment of eight nitrosamines using 2D and 3D HepaRG cell models
err2023-07-24
err5
PREAI
errSeo, 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
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Error-corrected next generation sequencing - Promises and challenges for genotoxicity and cancer risk assessment
err2023-07-01
err20
errOAAI
errMarchetti, Francesco; Cardoso, Renato; Chen, Connie L.; Douglas, George R.; Elloway, Joanne; Escobar, Patricia A.; Harper Jr, Tod; Heflich, Robert H.; Kidd, Darren; Lynch, Anthony M.; Parsons, Barbara L.; Salk, Jesse J.; Settivari, Raja S.; Smith-Roe, Stephanie L.; Witt, Kristine L.; Yauk, Carole L.; Young, Robert; Zhang, Shaofei; Minocherhomji, Sheroy
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Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
err2023-06-01
err11
errOAAI
errLi, 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
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Error-corrected next-generation sequencing to advance nonclinical genotoxicity and carcinogenicity testing
err2023-01-16
err19
PREAI
errMarchetti, Francesco; Cardoso, Renato; Chen, Connie L. L.; Douglas, George R.; Elloway, Joanne; Escobar, Patricia A.; Harper Jr, Tod; Heflich, Robert H.; Kidd, Darren; Lynch, Anthony M.; Myers, Meagan B.; Parsons, Barbara L.; Salk, Jesse J.; Settivari, Raja S.; Smith-Roe, Stephanie L.; Witt, Kristine L.; Yauk, Carole; Young, Robert R.; Zhang, Shaofei; Minocherhomji, Sheroy
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Genotoxicity evaluation of nitrosamine impurities using human TK6 cells transduced with cytochrome P450s
err2022-07-26
err12
PREAI
errLi, 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
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90-day nose-only inhalation toxicity study of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Sprague-Dawley rats
err2022-02-01
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PREAI
errHu, Shu-Chieh; Min, Seonggi; Kang, Hyun-Ki; Yang, Dong-Jin; Basavarajappa, Mallikarjuna; Lewis, Sherry M.; Davis, Kelly J.; Patton, Ralph E.; Bryant, Matthew S.; Sepehr, Estatira; Trbojevich, Raul; Pearce, Mason G.; Bishop, Michelle E.; Ding, Wei; Heflich, Robert H.; Maisha, MacKean P.; Felton, Robert; Chemerynski, Susan; Yee, Steven B.; Coraggio, Melis; Rosenfeldt, Hans; Yeager, R. Philip; Howard, Paul C.; Tang, Yunan
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14-Day Nose-Only Inhalation Toxicity and Haber's Rule Study of NNK in Sprague-Dawley Rats
err2021-07-30
err5
PREAI
errHu, Shu-Chieh; Min, Seonggi; Kang, Hyun-Ki; Yang, Dong-Jin; Lewis, Sherry M.; Davis, Kelly J.; Patton, Ralph E.; Bryant, Matthew S.; Sepehr, Estatira; Trbojevich, Raul; Pearce, Mason G.; Bishop, Michelle E.; Heflich, Robert H.; Maisha, MacKean P.; Felton, Robert; Chemerynski, Susan; Yee, Steven B.; Coraggio, Melis; Rosenfeldt, Hans; Yeager, R. Philip; Howard, Paul C.; Tang, Yunan
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Cigarette whole smoke solutions disturb mucin homeostasis in a human in vitro airway tissue model
err2018-11-01
err29
errOAAI
errCao, Xuefei; Wang, Yiying; Xiong, Rui; Muskhelishvili, Levan; Davis, Kelly; Richter, Patricia A.; Heflich, Robert H.
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Evaluating the Toxicity of Cigarette Whole Smoke Solutions in an Air-Liquid-Interface Human In Vitro Airway Tissue Model
err2017-01-23
err23
PREAI
errCao, Xuefei; Muskhelishvili, Levan; Latendresse, John; Richter, Patricia; Heflich, Robert H.
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In vivo genotoxicity of furan in F344 rats at cancer bioassay doses
err2012-06-01
err49
PREAI
errDing, Wei; Petibone, Dayton M.; Latendresse, John R.; Pearce, Mason G.; Muskhelishvili, Levan; White, Gene A.; Chang, Ching-Wei; Mittelstaedt, Roberta A.; Shaddock, Joseph G.; McDaniel, Lea P.; Doerge, Daniel R.; Morris, Suzanne M.; Bishop, Michelle E.; Manjanatha, Mugimane G.; Aidoo, Anane; Heflich, Robert H.
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Transgenic Animal Models in Toxicology: Historical Perspectives and Future Outlook
err2011-03-29
err77
errOAAI
errBoverhof, Darrell R.; Chamberlain, Mark P.; Elcombe, Clifford R.; Gonzalez, Frank J.; Heflich, Robert H.; Hernandez, Lya G.; Jacobs, Abigail C.; Jacobson-Kram, David; Luijten, Mirjam; Maggi, Adriana; Manjanatha, Mugimane G.; van Benthem, Jan; Gollapudi, B. Bhaskar
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In vivo mutation analysis using the ΦX174 transgenic mouse and comparisons with other transgenes and endogenous genes
err2010-12-01
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PREAI
errValentine, Carrie R.; Delongchamp, Robert R.; Pearce, Mason G.; Rainey, Heather F.; Dobrovolsky, Vasily N.; Malling, Heinrich V.; Heflich, Robert H.
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The Genotoxicity of Acrylamide and Glycidamide in Big Blue Rats
err2010-03-03
err62
errOAAI
errMei, Nan; McDaniel, Lea P.; Dobrovolsky, Vasily N.; Guo, Xiaoqing; Shaddock, Joseph G.; Mittelstaedt, Roberta A.; Azuma, Mizuo; Shelton, Sharon D.; McGarrity, Lynda J.; Doerge, Daniel R.; Heflich, Robert H.
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Current and Future Application of Genetic Toxicity Assays: The Role and Value of In Vitro Mammalian Assays
err2009-03-31
err39
errOAAI
errElespuru, Rosalie K.; Agarwal, Rajiv; Atrakchi, Aisar H.; Bigger, C. Anita H.; Heflich, Robert H.; Jagannath, Devaraya R.; Levy, Dan D.; Moore, Martha M.; Ouyang, Yanli; Robison, Timothy W.; Sotomayor, Rene E.; Cimino, Michael C.; Dearfield, Kerry L.
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