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N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da.
Bercu J, Dirat O, Dobo K, Jolly R, Kenyon M, Harvey J, Nudelman R, Smith G, Trejo-Martin A, Urquhart M. Bercu J, et al. Among authors: smith g. Regul Toxicol Pharmacol. 2024 Dec;154:105704. doi: 10.1016/j.yrtph.2024.105704. Epub 2024 Sep 24. Regul Toxicol Pharmacol. 2024. PMID: 39326488
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes.
Ponting DJ, Czich A, Felter SP, Glowienke S, Harvey JS, Nudelman R, Schlingemann J, Simon S, Smith GF, Teasdale A, Thomas R. Ponting DJ, et al. Regul Toxicol Pharmacol. 2024 Dec 9;156:105762. doi: 10.1016/j.yrtph.2024.105762. Online ahead of print. Regul Toxicol Pharmacol. 2024. PMID: 39662665 Free article. Review.
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