Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N‑Nitrosamine Impurities
Dobo, Krista L, Kenyon, Michelle O, Dirat, Olivier, Engel, Maria, Fleetwood, Andrew, Martin, Matthew, Mattano, Susan, Musso, Alyssa, McWilliams, James Christopher, Papanikolaou, Alexandros, Parris, Patricia, Whritenour, Jessica, Yu, Shu, Kalgutkar, Amit S
Published in Chemical research in toxicology (21.03.2022)
Published in Chemical research in toxicology (21.03.2022)
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Development and validation of an in vitro micronucleus assay platform in TK6 cells
Sobol, Zhanna, Homiski, Michael L., Dickinson, Donna A., Spellman, Richard A., Li, Dingzhou, Scott, Andrew, Cheung, Jennifer R., Coffing, Stephanie L., Munzner, Jennifer B., Sanok, Kelley E., Gunther, William C., Dobo, Krista L., Schuler, Maik
Published in Mutation research (04.07.2012)
Published in Mutation research (04.07.2012)
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Journal Article
A Strategy for the Risk Assessment of Human Genotoxic Metabolites
Dobo, Krista L, Obach, R. Scott, Luffer-Atlas, Debra, Bercu, Joel P
Published in Chemical research in toxicology (01.02.2009)
Published in Chemical research in toxicology (01.02.2009)
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Journal Article
Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency
Snodin, David J., Trejo-Martin, Alejandra, Ponting, David J., Smith, Graham F., Czich, Andreas, Cross, Kevin, Custer, Laura, Elloway, Joanne, Greene, Nigel, Kalgutkar, Amit S., Stalford, Susanne A., Tennant, Rachael E., Vock, Esther, Zalewski, Adam, Ziegler, Verena, Dobo, Krista L.
Published in Chemical research in toxicology (19.02.2024)
Published in Chemical research in toxicology (19.02.2024)
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Journal Article
A Kinetic Model for Assessing Potential Nitrosamine Carcinogenicity
Yu, Shu, McWilliams, J. Christopher, Dirat, Olivier, Dobo, Krista L., Kalgutkar, Amit S., Kenyon, Michelle O., Martin, Matthew T., Watt, Eric D., Schuler, Maik
Published in Chemical research in toxicology (19.08.2024)
Published in Chemical research in toxicology (19.08.2024)
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Journal Article
2‐Hydroxypyridine N‐Oxide is not genotoxic in vivo
Dobo, Krista L., Coffing, Stephanie, Gunther, William C., Homiski, Michael
Published in Environmental and molecular mutagenesis (01.08.2019)
Published in Environmental and molecular mutagenesis (01.08.2019)
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Journal Article
Establishing best practise in the application of expert review of mutagenicity under ICH M7
Barber, Chris, Amberg, Alexander, Custer, Laura, Dobo, Krista L., Glowienke, Susanne, Van Gompel, Jacky, Gutsell, Steve, Harvey, Jim, Honma, Masamitsu, Kenyon, Michelle O., Kruhlak, Naomi, Muster, Wolfgang, Stavitskaya, Lidiya, Teasdale, Andrew, Vessey, Jonathan, Wichard, Joerg
Published in Regulatory toxicology and pharmacology (01.10.2015)
Published in Regulatory toxicology and pharmacology (01.10.2015)
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Journal Article
A practical application of two in silico systems for identification of potentially mutagenic impurities
Greene, Nigel, Dobo, Krista L., Kenyon, Michelle O., Cheung, Jennifer, Munzner, Jennifer, Sobol, Zhanna, Sluggett, Gregory, Zelesky, Todd, Sutter, Andreas, Wichard, Joerg
Published in Regulatory toxicology and pharmacology (01.07.2015)
Published in Regulatory toxicology and pharmacology (01.07.2015)
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Journal Article
Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impurities
Sutter, Andreas, Amberg, Alexander, Boyer, Scott, Brigo, Alessandro, Contrera, Joseph F., Custer, Laura L., Dobo, Krista L., Gervais, Veronique, Glowienke, Susanne, Gompel, Jacky van, Greene, Nigel, Muster, Wolfgang, Nicolette, John, Reddy, M. Vijayaraj, Thybaud, Veronique, Vock, Esther, White, Angela T., Müller, Lutz
Published in Regulatory toxicology and pharmacology (01.10.2013)
Published in Regulatory toxicology and pharmacology (01.10.2013)
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Journal Article
Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop
Drewe, William C, Dobo, Krista L, Sobol, Zhanna, Bercu, Joel P, Parris, Patricia, Nicolette, John
Published in International journal of toxicology (01.05.2021)
Published in International journal of toxicology (01.05.2021)
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Journal Article
2‐Hydroxypyridine‐N‐oxide (HOPO): Equivocal in the ames assay
Dobo, Krista L., Cheung, Jennifer R., Gunther, William C., Kenyon, Michelle O., Zeiger, E.
Published in Environmental and molecular mutagenesis (01.05.2018)
Published in Environmental and molecular mutagenesis (01.05.2018)
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Journal Article
In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey
Dobo, Krista L., Greene, Nigel, Fred, Charlotta, Glowienke, Susanne, Harvey, James S., Hasselgren, Catrin, Jolly, Robert, Kenyon, Michelle O., Munzner, Jennifer B., Muster, Wolfgang, Neft, Robin, Vijayaraj Reddy, M., White, Angela T., Weiner, Sandy
Published in Regulatory toxicology and pharmacology (01.04.2012)
Published in Regulatory toxicology and pharmacology (01.04.2012)
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Journal Article
In Vivo Mutagenicity Testing of Arylboronic Acids and Esters
Masuda‐Herrera, Melisa J., Dobo, Krista L., Kenyon, Michelle O., Kenny, Julia D., Galloway, Sheila M., Escobar, Patricia A., Reddy, M. Vijayaraj, Jolly, Robert A., Trejo‐Martin, Alejandra, Brown, Caren, Mckeon, Marie, Young, Megan, Bruce, Shannon, Pant, Kamala, Dutta, Aparajita, Kulkarni, Rohan, Bercu, Joel P.
Published in Environmental and molecular mutagenesis (01.12.2019)
Published in Environmental and molecular mutagenesis (01.12.2019)
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Journal Article
Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities
Gunther, William C., Kenyon, Michelle O., Cheung, Jennifer R., Dugger, Robert W., Dobo, Krista L.
Published in Regulatory toxicology and pharmacology (01.12.2017)
Published in Regulatory toxicology and pharmacology (01.12.2017)
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Journal Article
Defining EMS and ENU dose–response relationships using the Pig-a mutation assay in rats
Dobo, Krista L., Fiedler, Ronald D., Gunther, William C., Thiffeault, Catherine J., Cammerer, Zoryana, Coffing, Stephanie L., Shutsky, Thomas, Schuler, Maik
Published in Mutation research (09.10.2011)
Published in Mutation research (09.10.2011)
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Journal Article
Compensatory erythropoiesis has no impact on the outcome of the in vivo Pig-a mutation assay in rats following treatment with the haemolytic agent 2-butoxyethanol
Kenyon, Michelle O, Coffing, Stephanie L, Ackerman, Joel I, Gunther, William C, Dertinger, Stephen D, Criswell, Kay, Dobo, Krista L
Published in Mutagenesis (01.05.2015)
Published in Mutagenesis (01.05.2015)
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