The year 2015 marks the 10th anniversary of the release of two ICH Harmonised Tripartite Guidelines that have governed the cardiac safety regulatory landscape, more specifically the proarrhythmic cardiac safety landscape, since their release in May 2005. ICH S7B addresses the non-clinical evaluation of the potential for delayed ventricular repolarisation (QT interval prolongation) by human pharmaceuticals, and ICH E14 addresses the clinical evaluation of QT interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, with a focus on the Thorough QT (TQT) Study. Our discussions in this paper focus on clinical evaluations.

Authors:

  • Snehal Kothari, MD, DM, FACC, FESC
  • Dilip R. Karnad, MD, FACP, FRCP
  • Gopi Krishna Panicker, BHMS, PGDCR
  • J. Rick Turner, PhD