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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: schrieber sj. 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: schrieber sj. 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.
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: schrieber sj. 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.
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors.
Sheikhy M, Schrieber SJ, Sun Q, Gershuny V, Matta MK, Bai JPF, Du X, Vegesna G, Shah A, Prentice K, Nalepinski C, Zineh I, Wang YM, Strauss DG, Florian J. Sheikhy M, et al. Among authors: schrieber sj. Clin Pharmacol Ther. 2023 Jan;113(1):71-79. doi: 10.1002/cpt.2769. Epub 2022 Nov 15. Clin Pharmacol Ther. 2023. PMID: 36282186 Clinical Trial.
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics.
Hyland PL, Chekka LMS, Samarth DP, Rosenzweig BA, Decker E, Mohamed EG, Guo Y, Matta MK, Sun Q, Wheeler W, Sanabria C, Weaver JL, Schrieber SJ, Florian J, Wang YM, Strauss DG. Hyland PL, et al. Among authors: schrieber sj. Clin Pharmacol Ther. 2023 Jan;113(1):98-107. doi: 10.1002/cpt.2778. Epub 2022 Nov 19. Clin Pharmacol Ther. 2023. PMID: 36308070 Clinical Trial.
26 results