Publications by authors named "Timothy McGovern"

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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

Regul Toxicol Pharmacol· November 2025

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Evaluating the lifetime cumulative dose as a basis for carcinogenic potency of nitrosamines - a key tenet underpinning less-than-lifetime approaches for establishing acceptable intake limits.
Susan P Felter, Ashley M Mudd, David J Ponting, Rob Thomas, Alisa Vespa, Timothy J McGovern

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, Timothy J McGovern

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

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, Timothy McGovern

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

Chem Biol Interact· August 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, Timothy J McGovern

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, Timothy J McGovern

Regul Toxicol Pharmacol· November 2024

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Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA).
Naomi L Kruhlak, Marianne Schmidt, Roland Froetschl, Stefan Graber, Bodo Haas, Timothy J McGovern

Regul Toxicol Pharmacol· June 2024

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ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup.
Todd Bourcier, Timothy McGovern, Tania Cavaliero, Geoffrey Ebere, Akiyoshi Nishikawa

Front Toxicol· April 2024

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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, Timothy J McGovern

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, Timothy J McGovern

Regul Toxicol Pharmacol· June 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, Timothy J McGovern

Arch Toxicol· November 2022

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Analyses of Transcriptomics Cell Signalling for Pre-Screening Applications in the Integrated Approach for Testing and Assessment of Non-Genotoxic Carcinogens.
Yusuke Oku, Federica Madia, Pierre Lau, Martin Paparella, Timothy McGovern

Int J Mol Sci· October 2022

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Current Trends of Practices in Nonclinical Toxicology: An Industry Survey.
Simon Authier, William J Brock, Wendy Halpern, Stephanie N Harris, David Jones, Timothy McGovern, Pamela D McGovern

Int J Toxicol· December 2021

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STP position paper: interpreting the significance of increased alveolar macrophages in rodents following inhalation of pharmaceutical materials.
Kristen J Nikula, Jeffrey E McCartney, Timothy McGovern, Glen K Miller, Marielle Odin

Toxicol Pathol· December 2014

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Trends in excipient safety evaluation.
Robert E Osterberg, Christopher C Demerlis, David W Hobson, Timothy J McGovern

Int J Toxicol· December 2011

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Overview of genotoxic impurities in pharmaceutical development.
Joel P Bercu, Krista L Dobo, Elmar Gocke, Timothy J McGovern

Int J Toxicol· February 2010

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Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation.
Douglas Ball, James Blanchard, David Jacobson-Kram, Roger O McClellan, Timothy McGovern

Toxicol Sci· June 2007

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Toxicological overview of impurities in pharmaceutical products.
David Jacobson-Kram, Timothy McGovern

Adv Drug Deliv Rev· January 2007

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