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Page 1
FDA/M-CERSI Co-Processed API Workshop Proceedings.
Schenck L, Patel P, Sood R, Bonaga L, Capella P, Dirat O, Erdemir D, Ferguson S, Gazziola C, Gorka LS, Graham L, Ho R, Hoag S, Hunde E, Kline B, Lee SL, Madurawe R, Marziano I, Merritt JM, Page S, Polli J, Ramanadham M, Sapru M, Stevens B, Watson T, Zhang H. Schenck L, et al. Among authors: dirat o. J Pharm Sci. 2023 Aug;112(8):2069-2078. doi: 10.1016/j.xphs.2023.01.006. Epub 2023 Jan 10. J Pharm Sci. 2023. PMID: 36638959
Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities.
Dobo KL, Kenyon MO, Dirat O, Engel M, Fleetwood A, Martin M, Mattano S, Musso A, McWilliams JC, Papanikolaou A, Parris P, Whritenour J, Yu S, Kalgutkar AS. Dobo KL, et al. Among authors: dirat o. Chem Res Toxicol. 2022 Mar 21;35(3):475-489. doi: 10.1021/acs.chemrestox.1c00369. Epub 2022 Feb 25. Chem Res Toxicol. 2022. PMID: 35212515 Free PMC article.
A Kinetic Model for Assessing Potential Nitrosamine Carcinogenicity.
Yu S, McWilliams JC, Dirat O, Dobo KL, Kalgutkar AS, Kenyon MO, Martin MT, Watt ED, Schuler M. Yu S, et al. Among authors: dirat o. Chem Res Toxicol. 2024 Aug 19;37(8):1382-1393. doi: 10.1021/acs.chemrestox.4c00133. Epub 2024 Jul 29. Chem Res Toxicol. 2024. PMID: 39075630
N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da.
Bercu J, Dirat O, Dobo K, Jolly R, Kenyon M, Harvey J, Nudelman R, Smith G, Trejo-Martin A, Urquhart M. Bercu J, et al. Among authors: dirat o. Regul Toxicol Pharmacol. 2024 Sep 24;154:105704. doi: 10.1016/j.yrtph.2024.105704. Online ahead of print. Regul Toxicol Pharmacol. 2024. PMID: 39326488
NK1 antagonists based on seven membered lactam scaffolds.
Elliott JM, Carlson EJ, Chicchi GG, Dirat O, Dominguez M, Gerhard U, Jelley R, Jones AB, Kurtz MM, Tsao Kl, Wheeldon A. Elliott JM, et al. Among authors: dirat o. Bioorg Med Chem Lett. 2006 Jun 1;16(11):2929-32. doi: 10.1016/j.bmcl.2006.02.080. Epub 2006 Mar 29. Bioorg Med Chem Lett. 2006. PMID: 16574413
Novel lactam NK1 antagonists with anti-emetic activity.
Hollingworth GJ, Carlson EJ, Castro JL, Chicchi GG, Clark N, Cooper LC, Dirat O, Salvo JD, Elliott JM, Kilburn R, Kurtz MM, Rycroft W, Tattersall FD, Tsao KL, Swain CJ. Hollingworth GJ, et al. Among authors: dirat o. Bioorg Med Chem Lett. 2006 Mar 1;16(5):1197-201. doi: 10.1016/j.bmcl.2005.11.111. Epub 2005 Dec 27. Bioorg Med Chem Lett. 2006. PMID: 16384700
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