Q&A for ICH E14 Guideline Revised with Input from IQ

January 5, 2016

The ICH E14 Implementation Working Group has revised the Questions and Answers document for the ICH E14 Guideline, "The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential For Non-Antiarrhythmic Drugs."  Specifically, the Q&A document now contains a revision to question 5.1, "Use of Concentration Response Modeling of QTc Data," which now provides a basis for regulators to waive the thorough QT (TQT) studies based on data from early phase 1 studies (see Darpo et al, 2015).

This important revision provides a data-based, streamlined approach for QT assessment, and is based on the studies conducted and published via the IQ-CSRC collaboration.