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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: zhou m. 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. Among authors: zhou m. Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60. Clin Pharmacol Ther. 2015. PMID: 25670536 Clinical Trial.
Improving the precision of QT measurements.
Darpo B, Fossa AA, Couderc JP, Zhou M, Schreyer A, Ticktin M, Zapesochny A. Darpo B, et al. Among authors: zhou m. Cardiol J. 2011;18(4):401-10. Cardiol J. 2011. PMID: 21769821 Free article. Clinical Trial.
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