The Division of Pharmacometrics plays a leading role on the QT Interdisciplinary Review Team (IRT). The QT IRT was established in 2006 to provide expert review advice to sponsors and review divisions on QT studies and to contribute to the evolution of the science by developing alternative methods for evaluating repolarization effects. Reviewers within the Division of Pharmacometrics review the clinical pharmacology components of all thorough QT studies submitted to the FDA. A critical part of the review is the characterization of the relationship, if any, between drug concentrations and change in QT. The concentration-QT relationship has been used to interpret results of QT studies, establish dose recommendations and provide informative drug labeling.
- Garnett CE et. al., Concentration-QT Relationshipd Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review. J Clin Pharmacol 2008 Jan;48(1):13-8
- Florian J et. al., A Modeling and Simulation Approach to Characterize Methadone QT Prolongation Using Pooled Data from Five Clinical Trials in MMT Patients. Clin Pharmacol Ther. 2012 Apr;91(4):666-72.
- Tornoe CW et. al., Creation of a Knowledge Management System for QT Analyses. J Clin Pharmacol. 2011 Jul;51(7):1035-42