HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions.
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| Title: | HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions. |
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| Authors: | Bercu J; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology, Foster City, CA, 94404, USA., Trejo-Martin A; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology, Foster City, CA, 94404, USA., Chen C; Health and Environmental Sciences Institute, Washington, DC, 20005, USA., Schuler M; Pfizer Research, Development, and Medical, Groton, CT, 06370, USA., Cheung J; Pfizer Research, Development, and Medical, Groton, CT, 06370, USA., Cheairs T; New York Medical College, Department of Pathology, Microbiology and Immunology, Valhalla, NY, 10595, USA., Lynch AM; GSK, Genetic & Investigative Toxicology, Stevenage, Hertfordshire, UK., Thomas D; GSK, Genetic & Investigative Toxicology, Stevenage, Hertfordshire, UK., Czich A; Sanofi, R&D Translational Medicine Preclinical Safety, D-69526, Frankfurt, Germany., Atrakchi A; US Food and Drug Administration/Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA., McGovern TJ; US Food and Drug Administration/Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA., Heflich RH; US Food and Drug Administration/National Center for Toxicological Research, AR, USA., Vespa A; Pharmaceutical Drugs Directorate, Health Canada, Ottawa, Ontario, Canada., Froetschl R; BfArM Federal Institute for Drugs and Medical Devices, Genetic and Reproductive Toxicology, Bonn, 53175, Germany., Yang Y; AbbVie Inc., Global Preclinical Safety, Chicago, IL, 60064, USA., Gandhi RD; Safety Sciences, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Cambridge, UK., Elloway J; Safety Sciences, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Cambridge, UK., Ziegler V; Bayer AG - Pharmaceuticals, In vitro Safety, 13342, Berlin, Germany., Hellmann A; Global Nonclinical Safety & DMPK, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany., Schaefer M; Global Nonclinical Safety & DMPK, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 06877, USA., Tennant RE; Lhasa Limited, Leeds, UK., Westerink W; Charles River Laboratories, Den Bosch, the Netherlands., Hoffmans R; Charles River Laboratories, Den Bosch, the Netherlands., Jolly R; Eli Lilly and Company, Indianapolis, IN, 46285, USA., Noteboom J; Eli Lilly and Company, Indianapolis, IN, 46285, USA., Gollapudi P; Inotiv, Rockville, MD, 20850, USA., Sobol Z; Nonclinical Drug Safety, MRL, Merck & Co., Inc., Rahway, NJ, USA., McGettigan KK; Nonclinical Drug Safety, MRL, Merck & Co., Inc., Rahway, NJ, USA., Christensen JS; Nonclinical Drug Safety, MRL, Merck & Co., Inc., Rahway, NJ, USA., Simon S; Merck Healthcare KGaA, 64293, Darmstadt, Germany., Dieckhoff J; Merck Healthcare KGaA, 64293, Darmstadt, Germany., Zeller A; F.Hoffmann-La Roche, Switzerland., Marchand C; F.Hoffmann-La Roche, Switzerland., Waese K; Sanofi, R&D Translational Medicine Preclinical Safety, D-69526, Frankfurt, Germany., Bishop ME; US Food and Drug Administration/National Center for Toxicological Research, AR, USA., Leavitt P; Bristol Myers Squibb, New Brunswick, NJ, 08901, USA., Hargreaves V; Labcorp, Genetic Toxicology, Harrogate, HG3 1PY, UK., Glick C; Cencora PharmaLex, Conshohocken, PA, 19428, USA., Liao Y; Cencora PharmaLex, Conshohocken, PA, 19428, USA., Elespuru R; US Food and Drug Administration/Center for Medical Devices (retired), Annapolis, MD, 21403, USA., Puglisi R; Health and Environmental Sciences Institute, Washington, DC, 20005, USA. Electronic address: rpuglisi@hesiglobal.org. |
| Source: | Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2025 Sep; Vol. 161, pp. 105835. Date of Electronic Publication: 2025 Apr 29. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 40311791 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Bercu+J%22">Bercu J</searchLink>; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology, Foster City, CA, 94404, USA.<br /><searchLink fieldCode="AU" term="%22Trejo-Martin+A%22">Trejo-Martin A</searchLink>; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology, Foster City, CA, 94404, USA.<br /><searchLink fieldCode="AU" term="%22Chen+C%22">Chen C</searchLink>; Health and Environmental Sciences Institute, Washington, DC, 20005, USA.<br /><searchLink fieldCode="AU" term="%22Schuler+M%22">Schuler M</searchLink>; Pfizer Research, Development, and Medical, Groton, CT, 06370, USA.<br /><searchLink fieldCode="AU" term="%22Cheung+J%22">Cheung J</searchLink>; Pfizer Research, Development, and Medical, Groton, CT, 06370, USA.<br /><searchLink fieldCode="AU" term="%22Cheairs+T%22">Cheairs T</searchLink>; New York Medical College, Department of Pathology, Microbiology and Immunology, Valhalla, NY, 10595, USA.<br /><searchLink fieldCode="AU" term="%22Lynch+AM%22">Lynch AM</searchLink>; GSK, Genetic & Investigative Toxicology, Stevenage, Hertfordshire, UK.<br /><searchLink fieldCode="AU" term="%22Thomas+D%22">Thomas D</searchLink>; GSK, Genetic & Investigative Toxicology, Stevenage, Hertfordshire, UK.<br /><searchLink fieldCode="AU" term="%22Czich+A%22">Czich A</searchLink>; Sanofi, R&D Translational Medicine Preclinical Safety, D-69526, Frankfurt, Germany.<br /><searchLink fieldCode="AU" term="%22Atrakchi+A%22">Atrakchi A</searchLink>; US Food and Drug Administration/Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22McGovern+TJ%22">McGovern TJ</searchLink>; US Food and Drug Administration/Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Heflich+RH%22">Heflich RH</searchLink>; US Food and Drug Administration/National Center for Toxicological Research, AR, USA.<br /><searchLink fieldCode="AU" term="%22Vespa+A%22">Vespa A</searchLink>; Pharmaceutical Drugs Directorate, Health Canada, Ottawa, Ontario, Canada.<br /><searchLink fieldCode="AU" term="%22Froetschl+R%22">Froetschl R</searchLink>; BfArM Federal Institute for Drugs and Medical Devices, Genetic and Reproductive Toxicology, Bonn, 53175, Germany.<br /><searchLink fieldCode="AU" term="%22Yang+Y%22">Yang Y</searchLink>; AbbVie Inc., Global Preclinical Safety, Chicago, IL, 60064, USA.<br /><searchLink fieldCode="AU" term="%22Gandhi+RD%22">Gandhi RD</searchLink>; Safety Sciences, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Cambridge, UK.<br /><searchLink fieldCode="AU" term="%22Elloway+J%22">Elloway J</searchLink>; Safety Sciences, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Cambridge, UK.<br /><searchLink fieldCode="AU" term="%22Ziegler+V%22">Ziegler V</searchLink>; Bayer AG - Pharmaceuticals, In vitro Safety, 13342, Berlin, Germany.<br /><searchLink fieldCode="AU" term="%22Hellmann+A%22">Hellmann A</searchLink>; Global Nonclinical Safety & DMPK, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.<br /><searchLink fieldCode="AU" term="%22Schaefer+M%22">Schaefer M</searchLink>; Global Nonclinical Safety & DMPK, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 06877, USA.<br /><searchLink fieldCode="AU" term="%22Tennant+RE%22">Tennant RE</searchLink>; Lhasa Limited, Leeds, UK.<br /><searchLink fieldCode="AU" term="%22Westerink+W%22">Westerink W</searchLink>; Charles River Laboratories, Den Bosch, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Hoffmans+R%22">Hoffmans R</searchLink>; Charles River Laboratories, Den Bosch, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Jolly+R%22">Jolly R</searchLink>; Eli Lilly and Company, Indianapolis, IN, 46285, USA.<br /><searchLink fieldCode="AU" term="%22Noteboom+J%22">Noteboom J</searchLink>; Eli Lilly and Company, Indianapolis, IN, 46285, USA.<br /><searchLink fieldCode="AU" term="%22Gollapudi+P%22">Gollapudi P</searchLink>; Inotiv, Rockville, MD, 20850, USA.<br /><searchLink fieldCode="AU" term="%22Sobol+Z%22">Sobol Z</searchLink>; Nonclinical Drug Safety, MRL, Merck & Co., Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22McGettigan+KK%22">McGettigan KK</searchLink>; Nonclinical Drug Safety, MRL, Merck & Co., Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Christensen+JS%22">Christensen JS</searchLink>; Nonclinical Drug Safety, MRL, Merck & Co., Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Simon+S%22">Simon S</searchLink>; Merck Healthcare KGaA, 64293, Darmstadt, Germany.<br /><searchLink fieldCode="AU" term="%22Dieckhoff+J%22">Dieckhoff J</searchLink>; Merck Healthcare KGaA, 64293, Darmstadt, Germany.<br /><searchLink fieldCode="AU" term="%22Zeller+A%22">Zeller A</searchLink>; F.Hoffmann-La Roche, Switzerland.<br /><searchLink fieldCode="AU" term="%22Marchand+C%22">Marchand C</searchLink>; F.Hoffmann-La Roche, Switzerland.<br /><searchLink fieldCode="AU" term="%22Waese+K%22">Waese K</searchLink>; Sanofi, R&D Translational Medicine Preclinical Safety, D-69526, Frankfurt, Germany.<br /><searchLink fieldCode="AU" term="%22Bishop+ME%22">Bishop ME</searchLink>; US Food and Drug Administration/National Center for Toxicological Research, AR, USA.<br /><searchLink fieldCode="AU" term="%22Leavitt+P%22">Leavitt P</searchLink>; Bristol Myers Squibb, New Brunswick, NJ, 08901, USA.<br /><searchLink fieldCode="AU" term="%22Hargreaves+V%22">Hargreaves V</searchLink>; Labcorp, Genetic Toxicology, Harrogate, HG3 1PY, UK.<br /><searchLink fieldCode="AU" term="%22Glick+C%22">Glick C</searchLink>; Cencora PharmaLex, Conshohocken, PA, 19428, USA.<br /><searchLink fieldCode="AU" term="%22Liao+Y%22">Liao Y</searchLink>; Cencora PharmaLex, Conshohocken, PA, 19428, USA.<br /><searchLink fieldCode="AU" term="%22Elespuru+R%22">Elespuru R</searchLink>; US Food and Drug Administration/Center for Medical Devices (retired), Annapolis, MD, 21403, USA.<br /><searchLink fieldCode="AU" term="%22Puglisi+R%22">Puglisi R</searchLink>; Health and Environmental Sciences Institute, Washington, DC, 20005, USA. Electronic address: rpuglisi@hesiglobal.org. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%228214983%22">Regulatory toxicology and pharmacology : RTP</searchLink> [Regul Toxicol Pharmacol] 2025 Sep; Vol. 161, pp. 105835. <i>Date of Electronic Publication: </i>2025 Apr 29. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>8214983 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1096-0295 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2202732300%22">02732300 </searchLink><i>NLM ISO Abbreviation: </i>Regul Toxicol Pharmacol <i>Subsets: </i>MEDLINE |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/j.yrtph.2025.105835 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 105835 Titles: – TitleFull: HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Bercu J – PersonEntity: Name: NameFull: Trejo-Martin A – PersonEntity: Name: NameFull: Chen C – PersonEntity: Name: NameFull: Schuler M – PersonEntity: Name: NameFull: Cheung J – PersonEntity: Name: NameFull: Cheairs T – PersonEntity: Name: NameFull: Lynch AM – PersonEntity: Name: NameFull: Thomas D – PersonEntity: Name: NameFull: Czich A – PersonEntity: Name: NameFull: Atrakchi A – PersonEntity: Name: NameFull: McGovern TJ – PersonEntity: Name: NameFull: Heflich RH – PersonEntity: Name: NameFull: Vespa A – PersonEntity: Name: NameFull: Froetschl R – PersonEntity: Name: NameFull: Yang Y – PersonEntity: Name: NameFull: Gandhi RD – PersonEntity: Name: NameFull: Elloway J – PersonEntity: Name: NameFull: Ziegler V – PersonEntity: Name: NameFull: Hellmann A – PersonEntity: Name: NameFull: Schaefer M – PersonEntity: Name: NameFull: Tennant RE – PersonEntity: Name: NameFull: Westerink W – PersonEntity: Name: NameFull: Hoffmans R – PersonEntity: Name: NameFull: Jolly R – PersonEntity: Name: NameFull: Noteboom J – PersonEntity: Name: NameFull: Gollapudi P – PersonEntity: Name: NameFull: Sobol Z – PersonEntity: Name: NameFull: McGettigan KK – PersonEntity: Name: NameFull: Christensen JS – PersonEntity: Name: NameFull: Simon S – PersonEntity: Name: NameFull: Dieckhoff J – PersonEntity: Name: NameFull: Zeller A – PersonEntity: Name: NameFull: Marchand C – PersonEntity: Name: NameFull: Waese K – PersonEntity: Name: NameFull: Bishop ME – PersonEntity: Name: NameFull: Leavitt P – PersonEntity: Name: NameFull: Hargreaves V – PersonEntity: Name: NameFull: Glick C – PersonEntity: Name: NameFull: Liao Y – PersonEntity: Name: NameFull: Elespuru R – PersonEntity: Name: NameFull: Puglisi R IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 09 Text: 2025 Sep Type: published Y: 2025 Identifiers: – Type: issn-electronic Value: 1096-0295 Numbering: – Type: volume Value: 161 Titles: – TitleFull: Regulatory toxicology and pharmacology : RTP Type: main |
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