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Meet our experts: c-QT Analyses

Assessing the risk of proarrythmic drug effects using concentration-QT analysis

November 17, 2020

Regulatory authorities have accepted concentration-QT modeling as the primary basis to classify the risk of proarrhythmic effects of a drug. For concentration-QT modeling to replace the thorough QT (TQT) study there are regulatory expectations, ranging from high-quality ECG data and study design
features to best modeling practices. Here Angela Äbelö and Jurgen Langenhorst share their experiences on implementing model-based concentration-QT analyses as part of cardiac safety programs for nonantiarrythmic drugs and describe their daily work with various clients in the pharmaceutical industry.