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Page 1
In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: an industry survey.
Dobo KL, Greene N, Fred C, Glowienke S, Harvey JS, Hasselgren C, Jolly R, Kenyon MO, Munzner JB, Muster W, Neft R, Reddy MV, White AT, Weiner S. Dobo KL, et al. Among authors: glowienke s. Regul Toxicol Pharmacol. 2012 Apr;62(3):449-55. doi: 10.1016/j.yrtph.2012.01.007. Epub 2012 Jan 31. Regul Toxicol Pharmacol. 2012. PMID: 22321701
Bacterial mutagenicity screening in the pharmaceutical industry.
Escobar PA, Kemper RA, Tarca J, Nicolette J, Kenyon M, Glowienke S, Sawant SG, Christensen J, Johnson TE, McKnight C, Ward G, Galloway SM, Custer L, Gocke E, O'Donovan MR, Braun K, Snyder RD, Mahadevan B. Escobar PA, et al. Among authors: glowienke s. Mutat Res. 2013 Apr-Jun;752(2):99-118. doi: 10.1016/j.mrrev.2012.12.002. Epub 2012 Dec 20. Mutat Res. 2013. PMID: 23262374 Review.
Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impurities.
Sutter A, Amberg A, Boyer S, Brigo A, Contrera JF, Custer LL, Dobo KL, Gervais V, Glowienke S, van Gompel J, Greene N, Muster W, Nicolette J, Reddy MV, Thybaud V, Vock E, White AT, Müller L. Sutter A, et al. Among authors: glowienke s. Regul Toxicol Pharmacol. 2013 Oct;67(1):39-52. doi: 10.1016/j.yrtph.2013.05.001. Epub 2013 May 10. Regul Toxicol Pharmacol. 2013. PMID: 23669331
Establishing best practise in the application of expert review of mutagenicity under ICH M7.
Barber C, Amberg A, Custer L, Dobo KL, Glowienke S, Van Gompel J, Gutsell S, Harvey J, Honma M, Kenyon MO, Kruhlak N, Muster W, Stavitskaya L, Teasdale A, Vessey J, Wichard J. Barber C, et al. Among authors: glowienke s. Regul Toxicol Pharmacol. 2015 Oct;73(1):367-77. doi: 10.1016/j.yrtph.2015.07.018. Epub 2015 Aug 4. Regul Toxicol Pharmacol. 2015. PMID: 26248005
Evaluation of a statistics-based Ames mutagenicity QSAR model and interpretation of the results obtained.
Barber C, Cayley A, Hanser T, Harding A, Heghes C, Vessey JD, Werner S, Weiner SK, Wichard J, Giddings A, Glowienke S, Parenty A, Brigo A, Spirkl HP, Amberg A, Kemper R, Greene N. Barber C, et al. Among authors: glowienke s. Regul Toxicol Pharmacol. 2016 Apr;76:7-20. doi: 10.1016/j.yrtph.2015.12.006. Epub 2015 Dec 18. Regul Toxicol Pharmacol. 2016. PMID: 26708083
It's difficult, but important, to make negative predictions.
Williams RV, Amberg A, Brigo A, Coquin L, Giddings A, Glowienke S, Greene N, Jolly R, Kemper R, O'Leary-Steele C, Parenty A, Spirkl HP, Stalford SA, Weiner SK, Wichard J. Williams RV, et al. Among authors: glowienke s. Regul Toxicol Pharmacol. 2016 Apr;76:79-86. doi: 10.1016/j.yrtph.2016.01.008. Epub 2016 Jan 16. Regul Toxicol Pharmacol. 2016. PMID: 26785392
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses.
Amberg A, Beilke L, Bercu J, Bower D, Brigo A, Cross KP, Custer L, Dobo K, Dowdy E, Ford KA, Glowienke S, Van Gompel J, Harvey J, Hasselgren C, Honma M, Jolly R, Kemper R, Kenyon M, Kruhlak N, Leavitt P, Miller S, Muster W, Nicolette J, Plaper A, Powley M, Quigley DP, Reddy MV, Spirkl HP, Stavitskaya L, Teasdale A, Weiner S, Welch DS, White A, Wichard J, Myatt GJ. Amberg A, et al. Among authors: glowienke s. Regul Toxicol Pharmacol. 2016 Jun;77:13-24. doi: 10.1016/j.yrtph.2016.02.004. Epub 2016 Feb 11. Regul Toxicol Pharmacol. 2016. PMID: 26877192 Free article.
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. Among authors: glowienke s. 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
Making reliable negative predictions of human skin sensitisation using an in silico fragmentation approach.
Chilton ML, Macmillan DS, Steger-Hartmann T, Hillegass J, Bellion P, Vuorinen A, Etter S, Smith BPC, White A, Sterchele P, De Smedt A, Glogovac M, Glowienke S, O'Brien D, Parakhia R. Chilton ML, et al. Among authors: glowienke s. Regul Toxicol Pharmacol. 2018 Jun;95:227-235. doi: 10.1016/j.yrtph.2018.03.015. Epub 2018 Mar 24. Regul Toxicol Pharmacol. 2018. PMID: 29580972
32 results