Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2849742 | American Heart Journal | 2009 | 11 Pages |
Abstract
Assessing the potential for a new drug to cause life-threatening arrhythmias is now an integral component of premarketing safety assessment. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline (ICH) E14 recommends the “Thorough QT Study” (TQT) to assess clinical QT risk. Such a study calls for careful evaluation of drug effects on the electrocardiographic QT interval at multiples of therapeutic exposure and with a positive control to confirm assay sensitivity. Yet for some drugs and diseases, elements of the TQT Study may be impractical or unethical. In these instances, alternative approaches to QT risk assessment must be considered. This article presents points to consider for evaluation of QT risk when alternative approaches are needed.
Related Topics
Health Sciences
Medicine and Dentistry
Cardiology and Cardiovascular Medicine
Authors
Edwin P. MD, PhD, John MD, Howard J. MD, Brian P. PhD, Christine E. PharmD, Stephen MD, Robert L. MD, Richard J. MD, Peter R. MD, Ignacio MD, Wendy R. PhD, Colette PhD, Shari L. MD, Yi PhD, Kathleen MD, Norman MD, PhD,