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Page 1
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: reddy mv. 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: reddy mv. 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
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: reddy mv. 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
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: reddy mv. 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.
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: reddy mv. 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.
In Vivo Mutagenicity Testing of Arylboronic Acids and Esters.
Masuda-Herrera MJ, Dobo KL, Kenyon MO, Kenny JD, Galloway SM, Escobar PA, Reddy MV, Jolly RA, Trejo-Martin A, Brown C, Mckeon M, Young M, Bruce S, Pant K, Dutta A, Kulkarni R, Bercu JP. Masuda-Herrera MJ, et al. Among authors: reddy mv. Environ Mol Mutagen. 2019 Dec;60(9):766-777. doi: 10.1002/em.22320. Epub 2019 Aug 17. Environ Mol Mutagen. 2019. PMID: 31335992
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: reddy mv. 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.
Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs).
Bercu JP, Masuda-Herrera M, Trejo-Martin A, Sura P, Jolly R, Kenyon M, Thomas R, Ponting DJ, Snodin D, Tuschl G, Simon S, De Vlieger K, Hutchinson R, Czich A, Glowienke S, Reddy MV, Johanssen S, Vock E, Claude N, Weaver RJ. Bercu JP, et al. Among authors: reddy mv. Regul Toxicol Pharmacol. 2023 Aug;142:105415. doi: 10.1016/j.yrtph.2023.105415. Epub 2023 May 29. Regul Toxicol Pharmacol. 2023. PMID: 37257751 Free article.
In Silico Assessment of Biomolecule Reactivity with Leachables.
Johnson C, Kiehl D, Christiaens P, Jodar FS, Cuyvers R, Bassan A, Beilke L, Bercu JP, Costelloe T, Cross KP, Feilden A, Filler R, Lucas MF, Masuda-Herrera MJ, Moghimi M, Morley N, Paskiet D, Pavan M, Pletz J, Reddy MV, Waine CJ, Myatt GJ. Johnson C, et al. Among authors: reddy mv. PDA J Pharm Sci Technol. 2024 Jun 28;78(3):214-236. doi: 10.5731/pdajpst.2022.012818. PDA J Pharm Sci Technol. 2024. PMID: 38942477
427 results