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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: strauss dg. 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.
Differentiating drug-induced multichannel block on the electrocardiogram: randomized study of dofetilide, quinidine, ranolazine, and verapamil.
Johannesen L, Vicente J, Mason JW, Sanabria C, Waite-Labott K, Hong M, Guo P, Lin J, Sørensen JS, Galeotti L, Florian J, Ugander M, Stockbridge N, Strauss DG. Johannesen L, et al. Among authors: strauss dg. Clin Pharmacol Ther. 2014 Nov;96(5):549-58. doi: 10.1038/clpt.2014.155. Epub 2014 Jul 23. Clin Pharmacol Ther. 2014. PMID: 25054430 Clinical Trial.
Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial.
Johannesen L, Vicente J, Mason JW, Erato C, Sanabria C, Waite-Labott K, Hong M, Lin J, Guo P, Mutlib A, Wang J, Crumb WJ, Blinova K, Chan D, Stohlman J, Florian J, Ugander M, Stockbridge N, Strauss DG. Johannesen L, et al. Among authors: strauss dg. Clin Pharmacol Ther. 2016 Feb;99(2):214-23. doi: 10.1002/cpt.205. Epub 2015 Nov 28. Clin Pharmacol Ther. 2016. PMID: 26259627 Free PMC article. Clinical Trial.
Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the "CiPA" Initiative and Design of a Prospective Clinical Validation Study.
Vicente J, Zusterzeel R, Johannesen L, Mason J, Sager P, Patel V, Matta MK, Li Z, Liu J, Garnett C, Stockbridge N, Zineh I, Strauss DG. Vicente J, et al. Among authors: strauss dg. Clin Pharmacol Ther. 2018 Jan;103(1):54-66. doi: 10.1002/cpt.896. Epub 2017 Nov 16. Clin Pharmacol Ther. 2018. PMID: 28986934 Free PMC article. Review.
FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".
Akbar M, Berry-Bibee E, Blithe DL, Day RS, Edelman A, Höchel J, Jamshidi R, Kim MJ, Li L, Purohit VS, Turpin JA, Scott PE, Strauss DG, Sun H, Tepper NK, Zhang L, Yu C. Akbar M, et al. Among authors: strauss dg. J Clin Pharmacol. 2018 Dec;58(12):1655-1665. doi: 10.1002/jcph.1285. Epub 2018 Aug 24. J Clin Pharmacol. 2018. PMID: 30144093 Free PMC article.
178 results