Zdrowie i gospodarka · 30/09/2020

FDA Releases Draft Guidance on Evaluating QT/QTc Interval Prolongation and Proarrhythmic Potential

The FDA has published a draft guidance for industry on evaluating the QT/QTc interval prolongation and proarrhythmic potential of pharmaceuticals, developed in collaboration with the International Council for Harmonisation, to provide recommendations on integrated risk assessment combining nonclinical and clinical data.