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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: wang ym. 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.
Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration.
Liu XI, Dallmann A, Wang YM, Green DJ, Burnham JM, Chiang B, Wu P, Sheng M, Lu K, van den Anker JN, Burckart GJ. Liu XI, et al. Among authors: wang ym. J Clin Pharmacol. 2019 Aug;59(8):1130-1143. doi: 10.1002/jcph.1406. Epub 2019 Mar 13. J Clin Pharmacol. 2019. PMID: 30865317 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: wang ym. 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.
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: wang ym. 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.
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: wang ym. 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.
2,605 results