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Utilizing PK and PD Biomarkers to Guide the First-in-Human Starting Dose Selection of MTBT1466A: A Novel Humanized Monoclonal Anti-TGFβ3 Antibody for the Treatment of Fibrotic Diseases.
Yadav R, Sukumaran S, Lutman J, Mitra MS, Halpern W, Sun T, Setiadi AF, Neighbors M, Sheng XR, Yip V, Shen BQ, Liu C, Han L, Ovacik AM, Wu Y, Glickstein S, Kunder R, Arron JR, Pan L, Kamath AV, Stefanich EG. Yadav R, et al. Among authors: halpern w. J Pharm Sci. 2023 Nov;112(11):2910-2920. doi: 10.1016/j.xphs.2023.07.005. Epub 2023 Jul 8. J Pharm Sci. 2023. PMID: 37429356 Free article.
Surfactant protein D is a biomarker of influenza-related pediatric lung injury.
Chakrabarti A, Nguyen A, Newhams MM, Ohlson MB, Yang X, Ulufatu S, Liu S, Park S, Xu M, Jiang J, Halpern WG, Anania VG, McBride JM, Rosenberger CM, Randolph AG; Pediatric Intensive Care Influenza (PICFLU) Investigators. Chakrabarti A, et al. Among authors: halpern wg. Pediatr Pulmonol. 2022 Feb;57(2):519-528. doi: 10.1002/ppul.25776. Epub 2021 Dec 7. Pediatr Pulmonol. 2022. PMID: 34842360 Free PMC 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: 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.
88 results