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Practice and challenges of thorough QT studies.
Stockbridge N, Zhang J, Garnett C, Malik M. Stockbridge N, et al. J Electrocardiol. 2012 Nov-Dec;45(6):582-7. doi: 10.1016/j.jelectrocard.2012.07.020. Epub 2012 Sep 19. J Electrocardiol. 2012. PMID: 22999322 Review.
The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".
Darpo B, Sarapa N, Garnett C, Benson C, Dota C, Ferber G, Jarugula V, Johannesen L, Keirns J, Krudys K, Ortemann-Renon C, Riley S, Rogers-Subramaniam D, Stockbridge N. Darpo B, et al. Ann Noninvasive Electrocardiol. 2014 Jan;19(1):70-81. doi: 10.1111/anec.12128. Epub 2013 Dec 30. Ann Noninvasive Electrocardiol. 2014. PMID: 24372708 Free PMC article. Review.
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.
68 results