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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: benson 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.
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: benson ct. 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
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: benson 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: benson ct. 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.
First-in-Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID-19.
Chen P, Datta G, Grace Li Y, Chien J, Price K, Chigutsa E, Brown-Augsburger P, Poorbaugh J, Fill J, Benschop RJ, Rouphael N, Kay A, Mulligan MJ, Saxena A, Fischer WA, Dougan M, Klekotka P, Nirula A, Benson C. Chen P, et al. Among authors: benson c. Clin Pharmacol Ther. 2021 Dec;110(6):1467-1477. doi: 10.1002/cpt.2405. Epub 2021 Oct 16. Clin Pharmacol Ther. 2021. PMID: 34455583 Free PMC article. Clinical Trial.
1,306 results