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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (III) A Randomized Trial with Interferon Beta-1a Products.
Florian J, Gershuny V, Sun Q, Schrieber SJ, Matta MK, Hazel A, Sheikhy M, Weaver JL, Hyland PL, Hsiao CH, Vegesna G, DePalma R, Shah A, Prentice K, Sanabria C, Wang YM, Strauss DG. Florian J, et al. Among authors: weaver jl. Clin Pharmacol Ther. 2023 Feb;113(2):339-348. doi: 10.1002/cpt.2784. Epub 2022 Dec 2. Clin Pharmacol Ther. 2023. PMID: 36324229 Clinical Trial.
Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.
Li J, Florian J, Campbell E, Schrieber SJ, Bai JPF, Weaver JL, Hyland PL, Thway TM, Matta MK, Lankapalli RH, Narayanasamy S, Dancy J, Zusterzeel R, Tyson JY, Prentice KW, Jackson KC, Patel V, Rouse RL, Wang YC, Strauss DG. Li J, et al. Among authors: weaver jl. Clin Pharmacol Ther. 2020 Jan;107(1):40-42. doi: 10.1002/cpt.1653. Epub 2019 Oct 31. Clin Pharmacol Ther. 2020. PMID: 31667825 Free PMC article. No abstract available.
Calibration and Validation of a Mechanistic COVID-19 Model for Translational Quantitative Systems Pharmacology - A Proof-of-Concept Model Development for Remdesivir.
Samieegohar M, Weaver JL, Howard KE, Chaturbedi A, Mann J, Han X, Zirkle J, Arabidarrehdor G, Rouse R, Florian J, Strauss DG, Li Z. Samieegohar M, et al. Among authors: weaver jl. Clin Pharmacol Ther. 2022 Oct;112(4):882-891. doi: 10.1002/cpt.2686. Epub 2022 Jun 29. Clin Pharmacol Ther. 2022. PMID: 35694844 Free PMC article.
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists.
Gershuny V, Sun Q, Schrieber SJ, Matta MK, Weaver JL, Ji P, Sheikhy M, Hsiao CH, Vegesna G, Shah A, Prentice K, Deering J, Wang YM, Strauss DG, Florian J. Gershuny V, et al. Among authors: weaver jl. Clin Pharmacol Ther. 2023 Jan;113(1):80-89. doi: 10.1002/cpt.2760. Epub 2022 Oct 21. Clin Pharmacol Ther. 2023. PMID: 36184697 Clinical Trial.
178 results