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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: maclachlan t. 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
Corrigendum to "Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics" [Regul. Toxicol. Pharmacol. (2017) 221-230].
de Zafra CLZ, Sasseville VG, Matsumoto S, Freichel C, Milton M, MacLachlan TK, Farman C, Raymond I, Gupta S, Newton R, Atzpodien EA, Thackaberry EA. de Zafra CLZ, et al. Regul Toxicol Pharmacol. 2017 Aug;88:364. doi: 10.1016/j.yrtph.2017.04.006. Epub 2017 Apr 18. Regul Toxicol Pharmacol. 2017. PMID: 28431771 No abstract available.
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: maclachlan tk. 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.
Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider.
Sato Y, Bando H, Di Piazza M, Gowing G, Herberts C, Jackman S, Leoni G, Libertini S, MacLachlan T, McBlane JW, Pereira Mouriès L, Sharpe M, Shingleton W, Surmacz-Cordle B, Yamamoto K, van der Laan JW. Sato Y, et al. Among authors: maclachlan t. Cytotherapy. 2019 Nov;21(11):1095-1111. doi: 10.1016/j.jcyt.2019.10.001. Epub 2019 Nov 9. Cytotherapy. 2019. PMID: 31711733 Free article. Review.
70 results