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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: florian j. 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.
Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
Mulugeta Y, Barrett JS, Nelson R, Eshete AT, Mushtaq A, Yao L, Glasgow N, Mulberg AE, Gonzalez D, Green D, Florian J, Krudys K, Seo S, Kim I, Chilukuri D, Burckart GJ. Mulugeta Y, et al. Among authors: florian j. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
Assessment of Multi-Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study.
Vicente J, Zusterzeel R, Johannesen L, Ochoa-Jimenez R, Mason JW, Sanabria C, Kemp S, Sager PT, Patel V, Matta MK, Liu J, Florian J, Garnett C, Stockbridge N, Strauss DG. Vicente J, et al. Among authors: florian j. Clin Pharmacol Ther. 2019 Apr;105(4):943-953. doi: 10.1002/cpt.1303. Epub 2019 Jan 18. Clin Pharmacol Ther. 2019. PMID: 30447156 Free PMC article. Clinical Trial.
Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial.
Matta MK, Zusterzeel R, Pilli NR, Patel V, Volpe DA, Florian J, Oh L, Bashaw E, Zineh I, Sanabria C, Kemp S, Godfrey A, Adah S, Coelho S, Wang J, Furlong LA, Ganley C, Michele T, Strauss DG. Matta MK, et al. Among authors: florian j. JAMA. 2019 Jun 4;321(21):2082-2091. doi: 10.1001/jama.2019.5586. JAMA. 2019. PMID: 31058986 Free PMC article. Clinical Trial.
Consideration of a Credibility Assessment Framework in Model-Informed Drug Development: Potential Application to Physiologically-Based Pharmacokinetic Modeling and Simulation.
Kuemmel C, Yang Y, Zhang X, Florian J, Zhu H, Tegenge M, Huang SM, Wang Y, Morrison T, Zineh I. Kuemmel C, et al. Among authors: florian j. CPT Pharmacometrics Syst Pharmacol. 2020 Jan;9(1):21-28. doi: 10.1002/psp4.12479. Epub 2019 Nov 10. CPT Pharmacometrics Syst Pharmacol. 2020. PMID: 31652029 Free PMC article.
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.
Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial.
Matta MK, Florian J, Zusterzeel R, Pilli NR, Patel V, Volpe DA, Yang Y, Oh L, Bashaw E, Zineh I, Sanabria C, Kemp S, Godfrey A, Adah S, Coelho S, Wang J, Furlong LA, Ganley C, Michele T, Strauss DG. Matta MK, et al. Among authors: florian j. JAMA. 2020 Jan 21;323(3):256-267. doi: 10.1001/jama.2019.20747. JAMA. 2020. PMID: 31961417 Free PMC article. Clinical Trial.
249 results