HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions.

Saved in:
Bibliographic Details
Title: HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions.
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
Description
ISSN:1096-0295
DOI:10.1016/j.yrtph.2025.105835