The Friday Podcast: Ten Years of Cardiac Safety
By: J. Rick Turner, PhD, DSc, FASH, FACC | May 01, 2015
Physicians and scientists in Quintiles' Cardiac Safety Center of Excellence recently published a review of cardiac safety investigations during the decade following the release of ICH E14. The review discusses the successes of these investigations, and also some unintended consequences that have led pharmaceutical companies to terminate development of some molecules that may have become useful drugs. Importantly, it also summarizes the results of a study entitled "Can early ECG assessment using exposure response analysis replace the Thorough QT Study?” and then considers their potential ramifications in the continued evolution of the cardiac safety landscape.
Chief Scientific Advisor, Quintiles Cardiac Safety Center of Excellence