Post by Allucent

FDA experience shows a 34% decrease in the proportion of TQT studies following updates to ICH E14 guidance, as more sponsors leverage concentration-QT modeling to answer the same regulatory questions more efficiently. In a recent case study, Allucent demonstrates how strategic concentration-QT (cQT) analysis helped sponsors: 🔸 Meet regulatory cardiac safety expectations 🔸 Avoid a dedicated Thorough QT (TQT) study 🔸 Deliver submission-ready analyses that supported regulatory approval 🔸 Accelerate development without sacrificing scientific rigor The takeaway? When cardiac safety planning starts early and is paired with the right clinical pharmacology expertise, it's often possible to avoid costly detours while maintaining confidence with regulators. Read the case study: https://lnkd.in/eTCvBX4Z #Allucent #BringingNewTherapiesToLight #ConcentrationQT #QT #ModelInformedDrugDevelopment