Current Edition

The Comprehensive In Vitro Proarrhythmia Assay: An Update

While the International Council on Harmonisation (ICH) S7B/E14 regulatory landscape has successfully prevented new drugs with an unrecognised propensity to induce the rare but potentially fatal ventricular arrhythmia Torsade de Pointes (Torsade) from entering the market, important and unanticipated limitations have become clear. Rick Turner, an Expert Consultant at DRT Strategies, Inc. and a member of the CSRC’s Executive Committee, discusses that the CiPA approach represents a paradigm shift involving strategies that have the potential to improve early detection of genuine proarrhythmic risk.