Why the study?
Does an improved conc-QTc modeling assessment leveraging intrasubject correlation patterns provide robust evaluation of QTc prolongation in early phase clinical trials?
Population
First-in-human crossover-like single ascending dose clinical pharmacology trials
Comparison
Improved drug concentration-QTc modeling… vs Standard conc-QTc assessment methods
Design
Other
Authors
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Early-phase conc-QTc modeling may reduce TQT study needs; leaves open full regulatory replacement and prospective validation.
Does an improved conc-QTc modeling assessment leveraging intrasubject correlation patterns provide robust evaluation of QTc prolongation in early phase clinical trials?
An improved conc-QTc modeling method leveraging intrasubject correlation patterns offers a robust alternative to dedicated thorough QTc studies in early phase drug development.
Mehrotra et al. (2017) studied this question.
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