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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.
Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.
Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N. Darpo B, et al. Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60. Clin Pharmacol Ther. 2015. PMID: 25670536 Clinical Trial.
A Phase I, Randomized, Double-Blinded, Placebo- and Moxifloxacin-Controlled, Four-Period Crossover Study To Evaluate the Effect of Gepotidacin on Cardiac Conduction as Assessed by 12-Lead Electrocardiogram in Healthy Volunteers.
Hossain M, Zhou M, Tiffany C, Dumont E, Darpo B. Hossain M, et al. Among authors: darpo b. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02385-16. doi: 10.1128/AAC.02385-16. Print 2017 May. Antimicrob Agents Chemother. 2017. PMID: 28223381 Free PMC 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.
127 results