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FDA perspective on sofosbuvir therapy for patients with chronic hepatitis C virus genotype 1 infection who did not respond to treatment with pegylated interferon and ribavirin.
Mishra P, Florian J, Qi K, Zeng W, Naeger LK, Donaldson E, Connelly S, O'Rear J, Price D, Murray J, Birnkrant D. Mishra P, et al. Among authors: florian j. Gastroenterology. 2014 Dec;147(6):1196-200. doi: 10.1053/j.gastro.2014.10.027. Epub 2014 Oct 27. Gastroenterology. 2014. PMID: 25449024 No abstract available.
FDA bridging analyses confirmed in clinical trial.
Mishra P, Florian J, Murray J. Mishra P, et al. Among authors: florian j. Hepatology. 2014 Dec;60(6):2134. doi: 10.1002/hep.27107. Epub 2014 Sep 25. Hepatology. 2014. PMID: 24591059 No abstract available.
U.S. Food and drug administration approval: obinutuzumab in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia.
Lee HZ, Miller BW, Kwitkowski VE, Ricci S, DelValle P, Saber H, Grillo J, Bullock J, Florian J, Mehrotra N, Ko CW, Nie L, Shapiro M, Tolnay M, Kane RC, Kaminskas E, Justice R, Farrell AT, Pazdur R. Lee HZ, et al. Among authors: florian j. Clin Cancer Res. 2014 Aug 1;20(15):3902-7. doi: 10.1158/1078-0432.CCR-14-0516. Epub 2014 May 13. Clin Cancer Res. 2014. PMID: 24824310 Clinical Trial.
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: florian j. 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.
Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.
Mehrotra N, Bhattaram A, Earp JC, Florian J, Krudys K, Lee JE, Lee JY, Liu J, Mulugeta Y, Yu J, Zhao P, Sinha V. Mehrotra N, et al. Among authors: florian j. Drug Metab Dispos. 2016 Jul;44(7):924-33. doi: 10.1124/dmd.116.069559. Epub 2016 Apr 14. Drug Metab Dispos. 2016. PMID: 27079249 Review.
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: florian j. 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.
245 results