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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: andrews l. Regul Toxicol Pharmacol. 2021 Apr;121:104872. doi: 10.1016/j.yrtph.2021.104872. Epub 2021 Jan 22. Regul Toxicol Pharmacol. 2021. PMID: 33485926
Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial.
Horvath C, Andrews L, Baumann A, Black L, Blanset D, Cavagnaro J, Hastings KL, Hutto DL, MacLachlan TK, Milton M, Reynolds T, Roberts S, Rogge M, Sims J, Treacy G, Warner G, Green JD. Horvath C, et al. Among authors: andrews l. Nat Rev Immunol. 2012 Oct;12(10):740; author reply 740. doi: 10.1038/nri3192-c1. Epub 2012 Aug 31. Nat Rev Immunol. 2012. PMID: 22941443 No abstract available.
Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges.
Brennan FR, Andrews L, Arulanandam AR, Blumel J, Fikes J, Grimaldi C, Lansita J, Loberg LI, MacLachlan T, Milton M, Parker S, Tibbitts J, Wolf J, Allamneni KP. Brennan FR, et al. Among authors: andrews l. Regul Toxicol Pharmacol. 2018 Oct;98:98-107. doi: 10.1016/j.yrtph.2018.07.009. Epub 2018 Jul 17. Regul Toxicol Pharmacol. 2018. PMID: 30026135
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: andrews l. 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.
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: andrews l. 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.
1,136 results