Why the study?
Does Concentration-QT (C-QT) modeling accurately predict QTc prolongation compared to thorough QTc (TQT) studies?
Population
Data from available single and multiple ascending-dose (SAD/MAD) studies for multiple compounds
Comparison
Concentration-QT (C-QT) modeling vs Thorough QTc (TQT) study
Design
Other
Authors
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C-QT modeling may reduce TQT study needs in early development; extends phase I/II validation but leaves broader adoption open pending larger trials.
Does Concentration-QT (C-QT) modeling accurately predict QTc prolongation compared to thorough QTc (TQT) studies?
Concentration-QT modeling using early-phase pharmacokinetic data can accurately predict QTc prolongation, potentially obviating the need for dedicated thorough QTc studies in drug development.
Rohatagi et al. (2009) studied this question.
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