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A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies.
Barber C, Antonucci V, Baumann JC, Brown R, Covey-Crump E, Elder D, Elliott E, Fennell JW, Gallou F, Ide ND, Jordine G, Kallemeyn JM, Lauwers D, Looker AR, Lovelle LE, McLaughlin M, Molzahn R, Ott M, Schils D, Oestrich RS, Stevenson N, Talavera P, Teasdale A, Urquhart MW, Varie DL, Welch D. Barber C, et al. Among authors: oestrich rs. Regul Toxicol Pharmacol. 2017 Nov;90:22-28. doi: 10.1016/j.yrtph.2017.08.008. Epub 2017 Aug 16. Regul Toxicol Pharmacol. 2017. PMID: 28822875
The utility of sulfonate salts in drug development.
Elder DP, Delaney E, Teasdale A, Eyley S, Reif VD, Jacq K, Facchine KL, Oestrich RS, Sandra P, David F. Elder DP, et al. Among authors: oestrich rs. J Pharm Sci. 2010 Jul;99(7):2948-61. doi: 10.1002/jps.22058. J Pharm Sci. 2010. PMID: 20112423 Review.
Development and validation of an automated static headspace gas chromatography-mass spectrometry (SHS-GC-MS) method for monitoring the formation of ethyl methane sulfonate from ethanol and methane sulfonic acid.
Jacq K, Delaney E, Teasdale A, Eyley S, Taylor-Worth K, Lipczynski A, Reif VD, Elder DP, Facchine KL, Golec S, Oestrich RS, Sandra P, David F. Jacq K, et al. Among authors: oestrich rs. J Pharm Biomed Anal. 2008 Dec 15;48(5):1339-44. doi: 10.1016/j.jpba.2008.09.028. Epub 2008 Sep 27. J Pharm Biomed Anal. 2008. PMID: 18996665