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Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant.
Murphy PJ, Yasuda S, Nakai K, Yoshinaga T, Hall N, Zhou M, Aluri J, Rege B, Moline M, Ferry J, Darpo B. Murphy PJ, et al. Among authors: darpo b. J Clin Pharmacol. 2017 Jan;57(1):96-104. doi: 10.1002/jcph.785. Epub 2016 Aug 4. J Clin Pharmacol. 2017. PMID: 27338807 Clinical Trial.
Combination of olanzapine and samidorphan has no clinically relevant effects on ECG parameters, including the QTc interval: Results from a phase 1 QT/QTc study.
Sun L, Yagoda S, Xue H, Brown R, Nangia N, McDonnell D, Rege B, von Moltke L, Darpo B. Sun L, et al. Among authors: darpo b. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Jun 8;100:109881. doi: 10.1016/j.pnpbp.2020.109881. Epub 2020 Jan 28. Prog Neuropsychopharmacol Biol Psychiatry. 2020. PMID: 32004636 Free article. Clinical Trial.
ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies.
Darpo B, Borin M, Ferber G, Galluppi GR, Hopkins SC, Landry I, Lo A, Rege B, Reyderman L, Sun L, Watanabe T, Xue H, Yasuda S. Darpo B, et al. J Clin Pharmacol. 2022 Dec;62(12):1480-1500. doi: 10.1002/jcph.2095. Epub 2022 Jul 1. J Clin Pharmacol. 2022. PMID: 35665514 Free PMC article. Review.
132 results