Dobo K - Search Results

1

Management of pharmaceutical ICH M7 (Q)SAR predictions - The impact of model updates.

Hasselgren C, Bercu J, Cayley A, Cross K, Glowienke S, Kruhlak N, Muster W, Nicolette J, Reddy MV, Saiakhov R, Dobo K. Hasselgren C, et al. Among authors: dobo k. Regul Toxicol Pharmacol. 2020 Dec;118:104807. doi: 10.1016/j.yrtph.2020.104807. Epub 2020 Oct 13. Regul Toxicol Pharmacol. 2020. PMID: 33058939 Free PMC article.

2

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.

Dobo KL, Greene N, Cyr MO, Caron S, Ku WW. Dobo KL, et al. Regul Toxicol Pharmacol. 2006 Apr;44(3):282-93. doi: 10.1016/j.yrtph.2006.01.004. Epub 2006 Feb 7. Regul Toxicol Pharmacol. 2006. PMID: 16464524

3

An evaluation of the sensitivity of the Ames assay to discern low-level mutagenic impurities.

Kenyon MO, Cheung JR, Dobo KL, Ku WW. Kenyon MO, et al. Regul Toxicol Pharmacol. 2007 Jun;48(1):75-86. doi: 10.1016/j.yrtph.2007.01.006. Epub 2007 Feb 4. Regul Toxicol Pharmacol. 2007. PMID: 17379368

4

A strategy for the risk assessment of human genotoxic metabolites.

Dobo KL, Obach RS, Luffer-Atlas D, Bercu JP. Dobo KL, et al. Chem Res Toxicol. 2009 Feb;22(2):348-56. doi: 10.1021/tx8004339. Chem Res Toxicol. 2009. PMID: 19170655

5

Overview of genotoxic impurities in pharmaceutical development.

Bercu JP, Dobo KL, Gocke E, McGovern TJ. Bercu JP, et al. Int J Toxicol. 2009 Nov-Dec;28(6):468-78. doi: 10.1177/1091581809349195. Int J Toxicol. 2009. PMID: 19966139 Review.

6

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. 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

7

Determination of compound-specific acceptable daily intakes for 11 mutagenic carcinogens used in pharmaceutical synthesis.

Ellis P, Kenyon M, Dobo K. Ellis P, et al. Among authors: dobo k. Regul Toxicol Pharmacol. 2013 Mar;65(2):201-13. doi: 10.1016/j.yrtph.2012.11.008. Epub 2012 Dec 7. Regul Toxicol Pharmacol. 2013. PMID: 23228434

8

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. 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

9

A practical application of two in silico systems for identification of potentially mutagenic impurities.

Greene N, Dobo KL, Kenyon MO, Cheung J, Munzner J, Sobol Z, Sluggett G, Zelesky T, Sutter A, Wichard J. Greene N, et al. Regul Toxicol Pharmacol. 2015 Jul;72(2):335-49. doi: 10.1016/j.yrtph.2015.05.008. Epub 2015 May 15. Regul Toxicol Pharmacol. 2015. PMID: 25980641

10

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. 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

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