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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: elder d. 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
Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs).
Elder DP, Lipczynski AM, Teasdale A. Elder DP, et al. J Pharm Biomed Anal. 2008 Nov 4;48(3):497-507. doi: 10.1016/j.jpba.2008.06.009. Epub 2008 Jun 25. J Pharm Biomed Anal. 2008. PMID: 18657926 Review.
This paper continues the review of the relevant scientific literature associated with the control and analysis of potential genotoxic impurities (PGIs) in active pharmaceutical ingredients (APIs). The initial review [D.P. Elder, A. Teasdale, A.M. Lipczynski, J. Phar …
This paper continues the review of the relevant scientific literature associated with the control and analysis of potential genotoxic impuri …
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. 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: elder dp. 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
Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.
Grady H, Elder D, Webster GK, Mao Y, Lin Y, Flanagan T, Mann J, Blanchard A, Cohen MJ, Lin J, Kesisoglou F, Hermans A, Abend A, Zhang L, Curran D. Grady H, et al. Among authors: elder d. J Pharm Sci. 2018 Jan;107(1):34-41. doi: 10.1016/j.xphs.2017.10.019. Epub 2017 Oct 24. J Pharm Sci. 2018. PMID: 29074376 Review.
630 results