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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: harvey j. 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.
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: harvey j. 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
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: harvey 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.
Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity.
Ahlberg E, Amberg A, Beilke LD, Bower D, Cross KP, Custer L, Ford KA, Van Gompel J, Harvey J, Honma M, Jolly R, Joossens E, Kemper RA, Kenyon M, Kruhlak N, Kuhnke L, Leavitt P, Naven R, Neilan C, Quigley DP, Shuey D, Spirkl HP, Stavitskaya L, Teasdale A, White A, Wichard J, Zwickl C, Myatt GJ. Ahlberg E, et al. Among authors: harvey j. Regul Toxicol Pharmacol. 2016 Jun;77:1-12. doi: 10.1016/j.yrtph.2016.02.003. Epub 2016 Feb 13. Regul Toxicol Pharmacol. 2016. PMID: 26879463
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: harvey 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
In silico toxicology protocols.
Myatt GJ, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger LT, Aptula A, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Burden N, Cammerer Z, Cronin MTD, Cross KP, Custer L, Dettwiler M, Dobo K, Ford KA, Fortin MC, Gad-McDonald SE, Gellatly N, Gervais V, Glover KP, Glowienke S, Van Gompel J, Gutsell S, Hardy B, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Hughes K, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kim MT, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Majer B, Masten S, Miller S, Moser J, Mumtaz M, Muster W, Neilson L, Oprea TI, Patlewicz G, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Ruiz P, Schilter B, Serafimova R, Simpson W, Stavitskaya L, Stidl R, Suarez-Rodriguez D, Szabo DT, Teasdale A, Trejo-Martin A, Valentin JP, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Hasselgren C. Myatt GJ, et al. Among authors: harvey js. Regul Toxicol Pharmacol. 2018 Jul;96:1-17. doi: 10.1016/j.yrtph.2018.04.014. Epub 2018 Apr 17. Regul Toxicol Pharmacol. 2018. PMID: 29678766 Free PMC article.
Managing emerging mutagenicity risks: Late stage mutagenic impurity control within the atovaquone second generation synthesis.
Urquhart MWJ, Bardsley B, Edwards AJ, Giddings A, Griva E, Harvey J, Hermitage S, King F, Leach S, Lesurf C, McKinlay C, Oxley P, Pham TN, Simpson A, Smith E, Stevenson N, Wade C, White A, Wooster N. Urquhart MWJ, et al. Among authors: harvey j. Regul Toxicol Pharmacol. 2018 Nov;99:22-32. doi: 10.1016/j.yrtph.2018.08.004. Epub 2018 Aug 15. Regul Toxicol Pharmacol. 2018. PMID: 30118726
3,221 results