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Lessons Learned From Hundreds of Thorough QT Studies

Joanne Zhang1, Huifang Chen1, Yi Tsong1

  • 11 Division of Biometrics VI, Office of Biostatistics, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Therapeutic Innovation & Regulatory Science
|September 18, 2018
PubMed
Summary

Analyzing the QTc-drug concentration relationship slope helps predict QT study outcomes. A positive slope strongly suggests positive QT study results, potentially avoiding unnecessary thorough QT (TQT) studies.

Keywords:
QTccoherencedrug plasma concentrationrelationshipsensitivityspecificity

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