New Approaches to Assessing Cardiac Drug Safety: Updates on ICH E14 and Moving Beyond Thorough QT Testing

All small molecules with systemic bioavailability must conduct a study to assess that drug's proarrhythmic liability during clinical development, usually before Phase III. Updated guidance from the International Conference on Harmonisation (ICH) now allows for specific Phase I data as a reasonable substitute for a Thorough-QT (TQT) dedicated trial. This webinar explores those options, the challenges, considerations and savings to both development costs and time.