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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. Among authors: smith gf. 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.
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. Regul Toxicol Pharmacol. 2024 Dec;154:105704. doi: 10.1016/j.yrtph.2024.105704. Epub 2024 Sep 24. Regul Toxicol Pharmacol. 2024. PMID: 39326488
Slow progress in mending the laws of botanical nomenclature.
Thiele KR, Smith GF. Thiele KR, et al. Among authors: smith gf. Nat Ecol Evol. 2024 Oct 11. doi: 10.1038/s41559-024-02569-4. Online ahead of print. Nat Ecol Evol. 2024. PMID: 39394523 No abstract available.
Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency.
Snodin DJ, Trejo-Martin A, Ponting DJ, Smith GF, Czich A, Cross K, Custer L, Elloway J, Greene N, Kalgutkar AS, Stalford SA, Tennant RE, Vock E, Zalewski A, Ziegler V, Dobo KL. Snodin DJ, et al. Among authors: smith gf. Chem Res Toxicol. 2024 Feb 19;37(2):181-198. doi: 10.1021/acs.chemrestox.3c00327. Epub 2024 Feb 5. Chem Res Toxicol. 2024. PMID: 38316048 Review.
Change in biological nomenclature is overdue and possible.
Roksandic M, Musiba C, Radović P, Lindal J, Wu XJ, Figueiredo E, Smith GF, Roksandic I, Bae CJ. Roksandic M, et al. Among authors: smith gf. Nat Ecol Evol. 2023 Aug;7(8):1166-1167. doi: 10.1038/s41559-023-02104-x. Nat Ecol Evol. 2023. PMID: 37337002 No abstract available.
210 results