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Q&A for ICH E14 Guideline Revised with Input from IQ
![Q&A for ICH E14 Guideline Revised with Input from IQ](https://iqconsortium.org/images/siteimages/groupsorts/IQ-LG_Clinical-Pharmacology.jpg)
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.