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Page 1
Preclinical safety assessment of JNJ-10450232 (NTM-006), a structural analog of acetaminophen, that does not cause hepatotoxicity at supratherapeutic doses.
Zhou J, De Jonghe S, Codd EE, Weiner S, Gallacher D, Stahle P, Kelley MF, Kuffner EK, Flores CM, Eichenbaum GE. Zhou J, et al. Among authors: weiner s. Regul Toxicol Pharmacol. 2023 Jan 4:105334. doi: 10.1016/j.yrtph.2023.105334. Online ahead of print. Regul Toxicol Pharmacol. 2023. PMID: 36608923 Free article.
Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an impurity in a drug product.
Eichenbaum G, Johnson M, Kirkland D, O'Neill P, Stellar S, Bielawne J, DeWire R, Areia D, Bryant S, Weiner S, Desai-Krieger D, Guzzie-Peck P, Evans DC, Tonelli A. Eichenbaum G, et al. Among authors: weiner s. Regul Toxicol Pharmacol. 2009 Oct;55(1):33-42. doi: 10.1016/j.yrtph.2009.05.018. Epub 2009 Jun 14. Regul Toxicol Pharmacol. 2009. PMID: 19500632 Review.
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: weiner s. 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.
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: weiner s. 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.
Evaluation of a statistics-based Ames mutagenicity QSAR model and interpretation of the results obtained.
Barber C, Cayley A, Hanser T, Harding A, Heghes C, Vessey JD, Werner S, Weiner SK, Wichard J, Giddings A, Glowienke S, Parenty A, Brigo A, Spirkl HP, Amberg A, Kemper R, Greene N. Barber C, et al. Among authors: weiner sk. Regul Toxicol Pharmacol. 2016 Apr;76:7-20. doi: 10.1016/j.yrtph.2015.12.006. Epub 2015 Dec 18. Regul Toxicol Pharmacol. 2016. PMID: 26708083
It's difficult, but important, to make negative predictions.
Williams RV, Amberg A, Brigo A, Coquin L, Giddings A, Glowienke S, Greene N, Jolly R, Kemper R, O'Leary-Steele C, Parenty A, Spirkl HP, Stalford SA, Weiner SK, Wichard J. Williams RV, et al. Among authors: weiner sk. Regul Toxicol Pharmacol. 2016 Apr;76:79-86. doi: 10.1016/j.yrtph.2016.01.008. Epub 2016 Jan 16. Regul Toxicol Pharmacol. 2016. PMID: 26785392
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: weiner s. 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
A comparison of transgenic rodent mutation and in vivo comet assay responses for 91 chemicals.
Kirkland D, Levy DD, LeBaron MJ, Aardema MJ, Beevers C, Bhalli J, Douglas GR, Escobar PA, Farabaugh CS, Guerard M, Johnson GE, Kulkarni R, Le Curieux F, Long AS, Lott J, Lovell DP, Luijten M, Marchetti F, Nicolette JJ, Pfuhler S, Roberts DJ, Stankowski LF Jr, Thybaud V, Weiner SK, Williams A, Witt KL, Young R. Kirkland D, et al. Among authors: weiner sk. Mutat Res Genet Toxicol Environ Mutagen. 2019 Mar;839:21-35. doi: 10.1016/j.mrgentox.2019.01.007. Epub 2019 Jan 18. Mutat Res Genet Toxicol Environ Mutagen. 2019. PMID: 30744809 Free PMC article.
1,136 results