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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.
Pharmetheus offers consulting services focused on the application of quantitative approaches to support drug development decisions..