This white paper explains concentration-QT (C-QT) modeling as a scientifically robust alternative to traditional thorough QT (TQT) studies. It details how exposure–response analysis during Phase I trials can assess cardiac safety earlier and more efficiently. The paper discusses electrophysiological principles, regulatory expectations, and trial design considerations, including ECG timing and heart-rate correction methods. Drawing on IQVIA experience, it highlights scenarios where C-QT is appropriate and limitations where TQT remains necessary. The report concludes that C-QT modeling can reduce cost, timelines, and development risk when applied rigorously.

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