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Page 1
Calculating qualified non-mutagenic impurity levels: Harmonization of approaches.
Graham JC, Powley MW, Udovic E, Glowienke S, Nicolette J, Parris P, Kenyon M, White A, Maisey A, Harvey J, Martin EA, Dowdy E, Masuda-Herrera M, Trejo-Martin A, Bercu J. Graham JC, et al. Among authors: nicolette j. Regul Toxicol Pharmacol. 2021 Nov;126:105023. doi: 10.1016/j.yrtph.2021.105023. Epub 2021 Aug 4. Regul Toxicol Pharmacol. 2021. PMID: 34363920
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: nicolette j. 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
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: nicolette j. 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.
Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses.
Amberg A, Andaya RV, Anger LT, Barber C, Beilke L, Bercu J, Bower D, Brigo A, Cammerer Z, Cross KP, Custer L, Dobo K, Gerets H, Gervais V, Glowienke S, Gomez S, Van Gompel J, Harvey J, Hasselgren C, Honma M, Johnson C, Jolly R, Kemper R, Kenyon M, Kruhlak N, Leavitt P, Miller S, Muster W, Naven R, Nicolette J, Parenty A, Powley M, Quigley DP, Reddy MV, Sasaki JC, Stavitskaya L, Teasdale A, Trejo-Martin A, Weiner S, Welch DS, White A, Wichard J, Woolley D, Myatt GJ. Amberg A, et al. Among authors: nicolette j. Regul Toxicol Pharmacol. 2019 Mar;102:53-64. doi: 10.1016/j.yrtph.2018.12.007. Epub 2018 Dec 15. Regul Toxicol Pharmacol. 2019. PMID: 30562600 Free PMC article.
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: nicolette j. 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.
Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines.
Trejo-Martin A, Bercu JP, Thresher A, Tennant RE, Thomas RF, Cross K, Czich A, Waese K, Nicolette JJ, Murray J, Sonders P, Kondratiuk A, Cheung JR, Thomas D, Lynch A, Harvey J, Glowienke S, Custer L, Escobar PA. Trejo-Martin A, et al. Among authors: nicolette jj. Regul Toxicol Pharmacol. 2022 Nov;135:105247. doi: 10.1016/j.yrtph.2022.105247. Epub 2022 Aug 23. Regul Toxicol Pharmacol. 2022. PMID: 35998738 Free article.
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: nicolette j. 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
An Evaluation of the Occupational Health Hazards of Peptide Couplers.
Graham JC, Trejo-Martin A, Chilton ML, Kostal J, Bercu J, Beutner GL, Bruen US, Dolan DG, Gomez S, Hillegass J, Nicolette J, Schmitz M. Graham JC, et al. Among authors: nicolette j. Chem Res Toxicol. 2022 Jun 20;35(6):1011-1022. doi: 10.1021/acs.chemrestox.2c00031. Epub 2022 May 9. Chem Res Toxicol. 2022. PMID: 35532537 Free PMC article.
51 results