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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.
A comparison of 24 chemicals in the six-well bacterial reverse mutation assay to the standard 100-mm Petri plate bacterial reverse mutation assay in two laboratories.
Nicolette J, Dakoulas E, Pant K, Crosby M, Kondratiuk A, Murray J, Sonders P, Kulkarni R, Jayakumar G, Mathur M, Patel A, Vicente R, Datta K, Kolaja K. Nicolette J, et al. Regul Toxicol Pharmacol. 2018 Dec;100:134-160. doi: 10.1016/j.yrtph.2018.10.005. Epub 2018 Oct 26. Regul Toxicol Pharmacol. 2018. PMID: 30401633
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. 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.
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. 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. 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.
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. Regul Toxicol Pharmacol. 2021 Nov;126:105023. doi: 10.1016/j.yrtph.2021.105023. Epub 2021 Aug 4. Regul Toxicol Pharmacol. 2021. PMID: 34363920
26 results