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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: dota c. 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. Among authors: dota c. Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60. Clin Pharmacol Ther. 2015. PMID: 25670536 Clinical Trial.
Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective.
Vargas HM, Rolf MG, Wisialowski TA, Achanzar W, Bahinski A, Bass A, Benson CT, Chaudhary KW, Couvreur N, Dota C, Engwall MJ, Michael Foley C, Gallacher D, Greiter-Wilke A, Guillon JM, Guth B, Himmel HM, Hegele-Hartung C, Ito M, Jenkinson S, Chiba K, Lagrutta A, Levesque P, Martel E, Okai Y, Peri R, Pointon A, Qu Y, Teisman A, Traebert M, Yoshinaga T, Gintant GA, Leishman DJ, Valentin JP. Vargas HM, et al. Among authors: dota c. Clin Pharmacol Ther. 2021 Feb;109(2):310-318. doi: 10.1002/cpt.2029. Epub 2020 Sep 24. Clin Pharmacol Ther. 2021. PMID: 32866317 Free PMC article. Review.
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Three-Way Crossover Study in Healthy Participants to Investigate the Effect of Savolitinib on the QTc Interval.
Sahota T, Dota CD, Vik T, Yan W, Verheijen RB, Walker S, Li Y, Goldwater R, Ghiorghiu D, Mellemgaard A, Ahmed GF. Sahota T, et al. Among authors: dota cd. Clin Pharmacol Drug Dev. 2021 May;10(5):521-534. doi: 10.1002/cpdd.896. Epub 2021 Jan 5. Clin Pharmacol Drug Dev. 2021. PMID: 33400845 Clinical Trial.
23 results