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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: matta mk. 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: matta mk. 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: matta mk. 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.
Determination of five positive control drugs in hERG external solution (buffer) by LC-MS/MS to support in vitro hERG assay as recommended by ICH S7B.
King TI, Indapurkar A, Tariq I, DePalma R, Mistry S, Alvarez-Baron C, Ismaiel OA, Wu W, Chiu K, Patel V, Rouse R, Strauss DG, Matta MK. King TI, et al. Among authors: matta mk. J Pharmacol Toxicol Methods. 2022 Nov-Dec;118:107229. doi: 10.1016/j.vascn.2022.107229. Epub 2022 Nov 9. J Pharmacol Toxicol Methods. 2022. PMID: 36334898 Free article.
New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science.
Chiu K, Racz R, Burkhart K, Florian J, Ford K, Iveth Garcia M, Geiger RM, Howard KE, Hyland PL, Ismaiel OA, Kruhlak NL, Li Z, Matta MK, Prentice KW, Shah A, Stavitskaya L, Volpe DA, Weaver JL, Wu WW, Rouse R, Strauss DG. Chiu K, et al. Among authors: matta mk. Front Med (Lausanne). 2023 Jan 19;9:1109541. doi: 10.3389/fmed.2022.1109541. eCollection 2022. Front Med (Lausanne). 2023. PMID: 36743666 Free PMC article. Review.
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: matta mk. 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.
hERG block potencies for 5 positive control drugs obtained per ICH E14/S7B Q&As best practices: Impact of recording temperature and drug loss.
Alvarez Baron C, Thiebaud N, Ren M, Viatchenko-Karpinski S, Indapurkar A, King T, Matta MK, Ismaiel OA, Patel V, Mashaee M, Vicente J, Wu WW. Alvarez Baron C, et al. Among authors: matta mk. J Pharmacol Toxicol Methods. 2022 Sep-Oct;117:107193. doi: 10.1016/j.vascn.2022.107193. Epub 2022 Jul 2. J Pharmacol Toxicol Methods. 2022. PMID: 35792285 Free article.
35 results