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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.
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: jolly r. 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
Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning.
Olson MJ, Faria EC, Hayes EP, Jolly RA, Barle EL, Molnar LR, Naumann BD, Pecquet AM, Shipp BK, Sussman RG, Weideman PA. Olson MJ, et al. Among authors: jolly ra. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S19-27. doi: 10.1016/j.yrtph.2016.05.024. Epub 2016 May 24. Regul Toxicol Pharmacol. 2016. PMID: 27233923 Review.
A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.
Hayes EP, Jolly RA, Faria EC, Barle EL, Bercu JP, Molnar LR, Naumann BD, Olson MJ, Pecquet AM, Sandhu R, Shipp BK, Sussman RG, Weideman PA. Hayes EP, et al. Among authors: jolly ra. Regul Toxicol Pharmacol. 2016 Aug;79 Suppl 1:S39-47. doi: 10.1016/j.yrtph.2016.06.001. Epub 2016 Jun 3. Regul Toxicol Pharmacol. 2016. PMID: 27267172 Review.
48 results