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Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides.
Bercu JP, Galloway SM, Parris P, Teasdale A, Masuda-Herrera M, Dobo K, Heard P, Kenyon M, Nicolette J, Vock E, Ku W, Harvey J, White A, Glowienke S, Martin EA, Custer L, Jolly RA, Thybaud V. Bercu JP, et al. Regul Toxicol Pharmacol. 2018 Apr;94:172-182. doi: 10.1016/j.yrtph.2018.02.001. Epub 2018 Feb 9. Regul Toxicol Pharmacol. 2018. PMID: 29408293
Strategy for genotoxicity testing--metabolic considerations.
Ku WW, Bigger A, Brambilla G, Glatt H, Gocke E, Guzzie PJ, Hakura A, Honma M, Martus HJ, Obach RS, Roberts S; Strategy Expert Group, IWGT. Ku WW, et al. Mutat Res. 2007 Feb 3;627(1):59-77. doi: 10.1016/j.mrgentox.2006.10.004. Epub 2006 Dec 1. Mutat Res. 2007. PMID: 17141553
60 results