Latest content from Pharmetheus.
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.