Current Edition

Which Protocol Should I Use: The Standard ICH E14 Thorough QT/QTc Study or Concentration-effect Modelling?

We now have two methods to fulfill the regulatory requirement
to thoroughly evaluate ECG effects of new drugs. Superficially,
the CEM approach may seem preferable because it gives early
answers at a lower cost and with considerable time savings.
However, there are many factors that must be considered in
making the choice between the CEM and the standard TQTS
approach. The purpose of this article by Jay W. Mason,
MD, Chief Medical Officer, Spaulding Clinical Research
and Professor of Medicine, University of Utah, is to help
pharmaceutical sponsors decide between the two accepted
methods for assessing ECG liability of new drugs.….pdf