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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: riley s. Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60. Clin Pharmacol Ther. 2015. PMID: 25670536 Clinical Trial.
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. Among authors: riley s. 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.
Cardiac Safety Research Consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward.
Darpo B, Garnett C, Benson CT, Keirns J, Leishman D, Malik M, Mehrotra N, Prasad K, Riley S, Rodriguez I, Sager P, Sarapa N, Wallis R. Darpo B, et al. Among authors: riley s. Am Heart J. 2014 Sep;168(3):262-72. doi: 10.1016/j.ahj.2014.06.003. Epub 2014 Jun 6. Am Heart J. 2014. PMID: 25173536
Scientific white paper on concentration-QTc modeling.
Garnett C, Bonate PL, Dang Q, Ferber G, Huang D, Liu J, Mehrotra D, Riley S, Sager P, Tornoe C, Wang Y. Garnett C, et al. Among authors: riley s. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):383-397. doi: 10.1007/s10928-017-9558-5. Epub 2017 Dec 5. J Pharmacokinet Pharmacodyn. 2018. PMID: 29209907 Review.
Correction to: Scientific white paper on concentration-QTc modeling.
Garnett C, Bonate PL, Dang Q, Ferber G, Huang D, Liu J, Mehrotra D, Riley S, Sager P, Tornoe C, Wang Y. Garnett C, et al. Among authors: riley s. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):399. doi: 10.1007/s10928-017-9565-6. J Pharmacokinet Pharmacodyn. 2018. PMID: 29330761
Cardiac risk assessment based on early Phase I data and PK-QTc analysis is concordant with the outcome of thorough QTc trials: an assessment based on eleven drug candidates.
Gaitonde P, Huh Y, Darpo B, Ferber G, Heimann G, Li J, Lu K, Sebastien B, Tsai K, Riley S. Gaitonde P, et al. Among authors: riley s. J Pharmacokinet Pharmacodyn. 2019 Dec;46(6):617-626. doi: 10.1007/s10928-019-09662-3. Epub 2019 Oct 30. J Pharmacokinet Pharmacodyn. 2019. PMID: 31667657
The effect of tafamidis on the QTc interval in healthy subjects.
Klamerus KJ, Watsky E, Moller R, Wang R, Riley S. Klamerus KJ, et al. Among authors: riley s. Br J Clin Pharmacol. 2015 Jun;79(6):918-25. doi: 10.1111/bcp.12561. Br J Clin Pharmacol. 2015. PMID: 25546001 Free PMC article. Clinical Trial.
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