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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: halpern w. 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.
Scientific and Regulatory Policy Committee Best Practices: Documentation of Sexual Maturity by Microscopic Evaluation in Nonclinical Safety Studies.
Vidal JD, Colman K, Bhaskaran M, de Rijk E, Fegley D, Halpern W, Jacob B, Kandori H, Manickam B, McKeag S, Parker GA, Regan KS, Sefing B, Thibodeau M, Vemireddi V, Werner J, Zalewska A. Vidal JD, et al. Among authors: halpern w. Toxicol Pathol. 2021 Jul;49(5):977-989. doi: 10.1177/0192623321990631. Epub 2021 Mar 4. Toxicol Pathol. 2021. PMID: 33661059 Review.
88 results