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The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Prior H, Andrews L, Cauvin A, Chien H, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Reid K, Schutte K, Sewell F, Trouba K, Ulrich P, van Aerts L, van Meer P, Weir L. Prior H, et al. Among authors: dempster m. Regul Toxicol Pharmacol. 2023 Feb;138:105339. doi: 10.1016/j.yrtph.2023.105339. Epub 2023 Jan 14. Regul Toxicol Pharmacol. 2023. PMID: 36649820 Free article. Review.
Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules - A survey of industry 2008-2019.
MacLachlan TK, Price S, Cavagnaro J, Andrews L, Blanset D, Cosenza ME, Dempster M, Galbreath E, Giusti AM, Heinz-Taheny KM, Fleurance R, Sutter E, Leach MW. MacLachlan TK, et al. Among authors: dempster m. Regul Toxicol Pharmacol. 2021 Apr;121:104872. doi: 10.1016/j.yrtph.2021.104872. Epub 2021 Jan 22. Regul Toxicol Pharmacol. 2021. PMID: 33485926
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Chien HT, Prior H, Andrews L, van Aerts L, Cauvin A, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Schutte K, Sewell F, Trouba K, Ulrich P, Weir L, van Meer P. Chien HT, et al. Among authors: dempster m. Regul Toxicol Pharmacol. 2023 Feb;138:105329. doi: 10.1016/j.yrtph.2022.105329. Epub 2022 Dec 30. Regul Toxicol Pharmacol. 2023. PMID: 36592682 Free article.
PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development.
Ivens IA, Achanzar W, Baumann A, Brändli-Baiocco A, Cavagnaro J, Dempster M, Depelchin BO, Rovira AR, Dill-Morton L, Lane JH, Reipert BM, Salcedo T, Schweighardt B, Tsuruda LS, Turecek PL, Sims J. Ivens IA, et al. Among authors: dempster m. Toxicol Pathol. 2015 Oct;43(7):959-83. doi: 10.1177/0192623315591171. Epub 2015 Aug 3. Toxicol Pathol. 2015. PMID: 26239651 Review.
155 results