SCS Capabilities — Modeling & Simulation of QTc Prolongation
QT prolongation has emerged as a primary biomarker for assessing the proarrhythmic risk of new drugs. In response, the thorough QT (TQT) study has become standard. Concentration?QT modeling (C-QT) is an important tool for assessing and communicating a drug?s true QT liability. Furthermore, C-QT modeling is strongly supported by FDA and is expected as part of every QT risk assessment.
At a cost of nearly $50,000 per subject, or more than $2 million for a reasonably sized TQT study, the stakes around proper TQT timing and study design are critically high.
Prior to the TQT, modeling of pooled Phase I/II datasets provide important information that can be used to save resources and make more informed decisions. At the TQT, C-QT modeling can ?save? a drug from a false-positive or otherwise explain a spurious outcome. Throughout development, C-QT modeling provides a richer understanding of the risk for QT prolongation across various populations, doses, and scenarios.
Pharsight has provided C-QT modeling services across various therapeutic areas for many sponsors:
- Overall risk-benefit calculations for decision-making
- Pooled C-QT modeling in early development
- Linking to population pharmacokinetic modeling
- C-QT modeling to inform TQT strategy
- Single study ECG/QT analyses