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Page 1
Safety assessment of protein A and derivation of a parenteral health-based exposure limit.
Graham JC, Anand SS, Bercu J, Besenhofer L, de Zafra C, Feng Y, Fisher C, Hillegass J, Hutchinson R, Jolly R, Moudgal C, Nicholas T, Olszova D, Schmitz M, Semmelmann F. Graham JC, et al. Among authors: de zafra c. Regul Toxicol Pharmacol. 2024 Nov;153:105700. doi: 10.1016/j.yrtph.2024.105700. Epub 2024 Sep 6. Regul Toxicol Pharmacol. 2024. PMID: 39243930 Free article.
FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations.
Ackley D, Birkebak J, Blumel J, Bourcier T, de Zafra C, Goodwin A, Halpern W, Herzyk D, Kronenberg S, Mauthe R, Shenton J, Shuey D, Wange RL. Ackley D, et al. Among authors: de zafra c. Regul Toxicol Pharmacol. 2023 Feb;138:105327. doi: 10.1016/j.yrtph.2022.105327. Epub 2022 Dec 28. Regul Toxicol Pharmacol. 2023. PMID: 36586472 Free article.
Increasing the Reuse of Protein Non-Naïve Nonhuman Primates in Pharmaceutical Drug Discovery and Development: An Overview and Industry Position on the Challenges and Benefits.
Mattis C, Bratcher N, Burns M, Carosino C, de Zafra C, Fancher RM, Georgi K, Graff C, Hukkanen RR, Johnson C, Lao Y, Lange A, Lee D, Lepherd M, Maguire S, Malisauskas M, Manuel M, Miranda S, Reed L, Santos R, Sayers B, Shaw D, Shuster D. Mattis C, et al. Among authors: de zafra c. Int J Toxicol. 2022 Aug;41(4):291-296. doi: 10.1177/10915818221101791. Epub 2022 Jun 2. Int J Toxicol. 2022. PMID: 35656559
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.
Balancing Efficacy and Safety of an Anti-DLL4 Antibody through Pharmacokinetic Modulation.
Couch JA, Zhang G, Beyer JC, de Zafra CL, Gupta P, Kamath AV, Lewin-Koh N, Tarrant J, Allamneni KP, Cain G, Yee S, Ross S, Cook R, Tsai SP, Ruppel J, Ridgway JB, Paluch M, Hass PE, Franklin J, Yan M. Couch JA, et al. Among authors: de zafra cl. Clin Cancer Res. 2016 Mar 15;22(6):1469-79. doi: 10.1158/1078-0432.CCR-15-1380. Epub 2015 Nov 20. Clin Cancer Res. 2016. PMID: 26589434