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Page 1
An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.
Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, Storer RD, Reddy MV, Kraynak A, Trela B, Bienvenu JG, Bjurström S, Bosmans V, Brewster D, Colman K, Dominick M, Evans J, Hailey JR, Kinter L, Liu M, Mahrt C, Marien D, Myer J, Perry R, Potenta D, Roth A, Sherratt P, Singer T, Slim R, Soper K, Fransson-Steen R, Stoltz J, Turner O, Turnquist S, van Heerden M, Woicke J, DeGeorge JJ. Sistare FD, et al. Among authors: reddy mv. Toxicol Pathol. 2011 Jun;39(4):716-44. doi: 10.1177/0192623311406935. Toxicol Pathol. 2011. PMID: 21666103
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.
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.
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 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
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.
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.
427 results