Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs).

Autor: Bercu JP; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA. Electronic address: joel.bercu@gilead.com., Masuda-Herrera M; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA., Trejo-Martin A; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA., Sura P; Gilead Sciences, Inc., Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA., Jolly R; Eli Lilly and Company, Indianapolis, IN, USA., Kenyon M; Pfizer Worldwide Research, Development and Medical, Drug Safety Research and Development, Groton, CT, USA., Thomas R; Lhasa Limited, Leeds, UK., Ponting DJ; Lhasa Limited, Leeds, UK., Snodin D; Xiphora Biopharma Consulting, Bristol, UK., Tuschl G; Merck KGaA, Global Chemical and Preclinical Safety, Darmstadt, Germany., Simon S; Merck KGaA, Global Chemical and Preclinical Safety, Darmstadt, Germany., De Vlieger K; Janssen Research & Development, Beerse, Antwerp, Belgium., Hutchinson R; Janssen Research & Development, Spring House, PA, USA., Czich A; Sanofi, R&D Preclinical Safety, Frankfurt, Germany., Glowienke S; Novartis AG, NIBR, Klybeckstrasse, Basel, Switzerland., Reddy MV; Merck Research Laboratories, West Point, PA, USA., Johanssen S; Bayer AG, Pharmaceuticals, Research & Development, Berlin, Germany., Vock E; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany., Claude N; Servier Paris-Saclay R&D Institute, Gif-sur-Yvette, France., Weaver RJ; Servier Paris-Saclay R&D Institute, Gif-sur-Yvette, France.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Aug; Vol. 142, pp. 105415. Date of Electronic Publication: 2023 May 29.

Commentary on "time-dependent selected reaction monitoring-based GC-MS/MS method for estimation of genotoxic impurities in a new antibacterial agent: alalevonadifloxin mesylate".

Autor: Snodin, D. J.¹ (AUTHOR) snodind@xiphora.com, Teasdale, A.² (AUTHOR), Elder, D. P.³ (AUTHOR)

Publikováno v: Journal of Analytical Science & Technology. 11/10/2020, Vol. 11 Issue 1, pN.PAG-N.PAG. 1p.

Structure-mutagenicity relationships on quinoline and indole analogues in the Ames test.

Autor: Kurakami, Masaki¹ (AUTHOR) m-kurakami@hhc.eisai.co.jp, Hakura, Atsushi¹ (AUTHOR), Sato, Rika² (AUTHOR), Kawade, Akihiro² (AUTHOR), Yamagata, Takeshi³ (AUTHOR), Koyama, Naoki¹ (AUTHOR), Kakiuchi, Dai¹ (AUTHOR), Asakura, Shoji¹ (AUTHOR)

Publikováno v: Genes & Environment. 11/14/2024, Vol. 46 Issue 1, p1-10. 10p.

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?

Autor: Amberg A; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Höchst, Frankfurt am Main, Germany., Anger LT; Sanofi, R&D Preclinical Safety Frankfurt, Industriepark Höchst, Frankfurt am Main, Germany., Bercu J; Gilead Sciences, Nonclinical Safety and Pathobiology, Foster City, CA, USA., Bower D; Leadscope, Inc., Columbus, OH, USA., Cross KP; Leadscope, Inc., Columbus, OH, USA., Custer L; Bristol-Myers Squibb, Drug Safety Evaluation, New Brunswick, NJ, USA., Harvey JS; GlaxoSmithKline Pre-Clinical Development, Ware, Hertfordshire, UK., Hasselgren C; Genentech, Inc., Safety Assessment, South San Francisco, CA, USA., Honma M; National Institute of Health Sciences, Division of Genetics & Mutagenesis, Kamiyoga, Setagaya-ku, Tokyo, Japan., Johnson C; Leadscope, Inc., Columbus, OH, USA., Jolly R; Toxicology Division, Eli Lilly and Company, Indianapolis, IN, USA., Kenyon MO; Pfizer Worldwide Research and Development, Drug Safety, Genetic Toxicology, Groton, CT, USA., Kruhlak NL; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA., Leavitt P; Bristol-Myers Squibb, Drug Safety Evaluation, New Brunswick, NJ, USA., Quigley DP; Leadscope, Inc., Columbus, OH, USA., Miller S; Leadscope, Inc., Columbus, OH, USA., Snodin D; Xiphora Biopharma Consulting, Bristol, UK., Stavitskaya L; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA., Teasdale A; AstraZeneca, Pharmaceutical Technology and Development, Macclesfield, Cheshire, UK., Trejo-Martin A; AstraZeneca, Pharmaceutical Technology and Development, Macclesfield, Cheshire, UK., White AT; GlaxoSmithKline Pre-Clinical Development, Ware, Hertfordshire, UK., Wichard J; Bayer AG, Pharmaceuticals Division, Investigational Toxicology, Muellerstr, Berlin, Germany., Myatt GJ; Leadscope, Inc., Columbus, OH, USA.

Publikováno v: Mutagenesis [Mutagenesis] 2019 Mar 06; Vol. 34 (1), pp. 67-82.

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