Smarter QT Risk Evaluation: Streamlined Pathways for Cardiac Safety Assessment
Shreya Yeramilli
Drug‑induced QT prolongation and torsades de pointes (TdP) remain critical safety concerns in drug development, driving regulators to refine guidance over the past two decades. Since 2005, ICH E14 has required a robust assessment of QTc prolongation risk, but the field has shifted from a one‑size‑fits‑all thorough QT (TQT) study toward more flexible, efficient pathways that leverage early clinical pharmacology data and integrated nonclinical evidence. […] The post Smarter QT Risk Evaluation: St