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Practice and challenges of thorough QT studies.

Norman Stockbridge1, Joanne Zhang, Christine Garnett

  • 1Division of Cardiovascular and Renal Products, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Journal of Electrocardiology
|September 25, 2012
PubMed
Summary

Thorough QT (TQT) studies are crucial for identifying drugs that may cause Torsade de Pointes (TdP) tachycardia. This review discusses TQT study concepts, statistical evaluation, and modeling, offering efficiency improvements for drug development.

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