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Page 1
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.
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.
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: kenyon mo. 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
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: kenyon mo. 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
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: kenyon mo. 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.
Genetic toxicology in silico protocol.
Hasselgren C, Ahlberg E, Akahori Y, Amberg A, Anger LT, Atienzar F, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Cammerer Z, Cronin MTD, Crooks I, Cross KP, Custer L, Dobo K, Doktorova T, Faulkner D, Ford KA, Fortin MC, Frericks M, Gad-McDonald SE, Gellatly N, Gerets H, Gervais V, Glowienke S, Van Gompel J, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Barton-Maclaren TS, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Masten S, Miller S, Moudgal C, Muster W, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Schilter B, Snyder RD, Stavitskaya L, Stidl R, Szabo DT, Teasdale A, Tice RR, Trejo-Martin A, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Myatt GJ. Hasselgren C, et al. Among authors: kenyon mo. Regul Toxicol Pharmacol. 2019 Oct;107:104403. doi: 10.1016/j.yrtph.2019.104403. Epub 2019 Jun 11. Regul Toxicol Pharmacol. 2019. PMID: 31195068 Free PMC article.
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