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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: wange rl. 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.
Toward implementing virtual control groups in nonclinical safety studies.
Golden E, Allen D, Amberg A, Anger LT, Baker E, Baran SW, Bringezu F, Clark M, Duchateau-Nguyen G, Escher SE, Giri V, Grevot A, Hartung T, Li D, Lotfi L, Muster W, Snyder K, Wange R, Steger-Hartmann T. Golden E, et al. ALTEX. 2024;41(2):282-301. doi: 10.14573/altex.2310041. Epub 2023 Dec 1. ALTEX. 2024. PMID: 38043132 Free article.
3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration.
Wang H, Brown PC, Chow ECY, Ewart L, Ferguson SS, Fitzpatrick S, Freedman BS, Guo GL, Hedrich W, Heyward S, Hickman J, Isoherranen N, Li AP, Liu Q, Mumenthaler SM, Polli J, Proctor WR, Ribeiro A, Wang JY, Wange RL, Huang SM. Wang H, et al. Among authors: wange rl. Clin Transl Sci. 2021 Sep;14(5):1659-1680. doi: 10.1111/cts.13066. Epub 2021 Jun 16. Clin Transl Sci. 2021. PMID: 33982436 Free PMC article. Review.
An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).
Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. Avila AM, et al. Among authors: wange rl. Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. Regul Toxicol Pharmacol. 2020. PMID: 32325112
50 results