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Page 1
Skin sensitization in silico protocol.
Johnson C, Ahlberg E, Anger LT, Beilke L, Benigni R, Bercu J, Bobst S, Bower D, Brigo A, Campbell S, Cronin MTD, Crooks I, Cross KP, Doktorova T, Exner T, Faulkner D, Fearon IM, Fehr M, Gad SC, Gervais V, Giddings A, Glowienke S, Hardy B, Hasselgren C, Hillegass J, Jolly R, Krupp E, Lomnitski L, Magby J, Mestres J, Milchak L, Miller S, Muster W, Neilson L, Parakhia R, Parenty A, Parris P, Paulino A, Paulino AT, Roberts DW, Schlecker H, Stidl R, Suarez-Rodrigez D, Szabo DT, Tice RR, Urbisch D, Vuorinen A, Wall B, Weiler T, White AT, Whritenour J, Wichard J, Woolley D, Zwickl C, Myatt GJ. Johnson C, et al. Among authors: parris p. Regul Toxicol Pharmacol. 2020 Oct;116:104688. doi: 10.1016/j.yrtph.2020.104688. Epub 2020 Jul 1. Regul Toxicol Pharmacol. 2020. PMID: 32621976 Free PMC article.
Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides.
Bercu JP, Galloway SM, Parris P, Teasdale A, Masuda-Herrera M, Dobo K, Heard P, Kenyon M, Nicolette J, Vock E, Ku W, Harvey J, White A, Glowienke S, Martin EA, Custer L, Jolly RA, Thybaud V. Bercu JP, et al. Among authors: parris p. Regul Toxicol Pharmacol. 2018 Apr;94:172-182. doi: 10.1016/j.yrtph.2018.02.001. Epub 2018 Feb 9. Regul Toxicol Pharmacol. 2018. PMID: 29408293
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.
Parris P, Martin EA, Stanard B, Glowienke S, Dolan DG, Li K, Binazon O, Giddings A, Whelan G, Masuda-Herrera M, Bercu J, Broschard T, Bruen U, Callis CM, Stults CLM, Erexson GL, Cruz MT, Nagao LM. Parris P, et al. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429
Calculating qualified non-mutagenic impurity levels: Harmonization of approaches.
Graham JC, Powley MW, Udovic E, Glowienke S, Nicolette J, Parris P, Kenyon M, White A, Maisey A, Harvey J, Martin EA, Dowdy E, Masuda-Herrera M, Trejo-Martin A, Bercu J. Graham JC, et al. Among authors: parris p. Regul Toxicol Pharmacol. 2021 Nov;126:105023. doi: 10.1016/j.yrtph.2021.105023. Epub 2021 Aug 4. Regul Toxicol Pharmacol. 2021. PMID: 34363920
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls).
Masuda-Herrera MJ, Bercu JP, Broschard TH, Burild A, Hasselgren C, Parris P, Ford LC, Graham J, Stanard B, Comerford M, Lettiere D, Erler S, Callis CM, Morinello E, Muster W, Martin EA, Griffin TR, Nagao L, Cruz M. Masuda-Herrera MJ, et al. Among authors: parris p. PDA J Pharm Sci Technol. 2022 Sep-Oct;76(5):369-383. doi: 10.5731/pdajpst.2021.012693. Epub 2022 Jan 14. PDA J Pharm Sci Technol. 2022. PMID: 35031541
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: parris p. 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.
Framework for sensitization assessment of extractables and leachables in pharmaceuticals.
Parris P, Whelan G, Burild A, Whritenour J, Bruen U, Bercu J, Callis C, Graham J, Johann E, Griffin T, Kohan M, Martin EA, Masuda-Herrera M, Stanard B, Tien E, Cruz M, Nagao L. Parris P, et al. Crit Rev Toxicol. 2022 Feb;52(2):125-138. doi: 10.1080/10408444.2022.2065966. Epub 2022 Jun 15. Crit Rev Toxicol. 2022. PMID: 35703156 Review.
Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis.
Parris P, Whelan G, Burild A, Whritenour J, Bruen U, Bercu J, Callis C, Chilton ML, Graham J, Johann E, Johnson C, Griffin T, Kohan M, Martin EA, Masuda-Herrera M, Stanard B, Cruz MT, Nagao L. Parris P, et al. PDA J Pharm Sci Technol. 2023 Sep 15:pdajpst.2022.012811. doi: 10.5731/pdajpst.2022.012811. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37714567
47 results