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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: herzyk d. 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.
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: herzyk d. 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: herzyk d. 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.
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab.
Hutchins B, Starling GC, McCoy MA, Herzyk D, Poulet FM, Dulos J, Liu L, Kang SP, Fayadat-Dilman L, Hsieh M, Andrews CL, Ayanoglu G, Cullen C, Malefyt RW, Kastelein RA, Saux SL, Lee J, Li S, Malashock D, Sadekova S, Soder G, van Eenennaam H, Willingham A, Yu Y, Streuli M, Carven GJ, van Elsas A. Hutchins B, et al. Among authors: herzyk d. Mol Cancer Ther. 2020 Jun;19(6):1298-1307. doi: 10.1158/1535-7163.MCT-19-0774. Epub 2020 Mar 30. Mol Cancer Ther. 2020. PMID: 32229606
Drug safety Africa: An overview of safety pharmacology & toxicology in South Africa.
Guth BD, Grobler AF, Frazier KS, Greiter-Wilke A, Herzyk D, Hough TA, Khan AA, Markert M, Smith JD, Svenson KL, Wells S, Pugsley MK. Guth BD, et al. Among authors: herzyk d. J Pharmacol Toxicol Methods. 2019 Jul-Aug;98:106579. doi: 10.1016/j.vascn.2019.106579. Epub 2019 May 11. J Pharmacol Toxicol Methods. 2019. PMID: 31085319 Free article. Review.
51 results