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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: harvey js. 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-Nitrosodimethylamine investigations in Muta™Mouse define point-of-departure values and demonstrate less-than-additive somatic mutant frequency accumulations.
Lynch AM, Howe J, Hildebrand D, Harvey JS, Burman M, Harte DSG, Chen L, Kmett C, Shi W, McHugh CF, Patel KK, Junnotula V, Kenny J, Haworth R, Wills JW. Lynch AM, et al. Among authors: harvey js. Mutagenesis. 2024 Mar 12;39(2):96-118. doi: 10.1093/mutage/geae001. Mutagenesis. 2024. PMID: 38183622 Free PMC article.
81 results