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The Thorough QT Study: Isn’t There a Better Way to Do This?
Session Chair(s)
Charles Benson, MD, PhD
Senior Director Clinical Phamacology
Eli Lilly and Company, United States
QT studies are required for drug approval but are expensive and inappropriately scheduled. A better repolarization assessment can be achieved earlier and at lower cost and risk to subjects as compared to the ICH E-14 thorough QT study approach. This session will review efforts now underway to revise the process for assessing repolarization and related arrhythmia risk during drug development.
Learning Objective : Define the principles underlying assessment of a drug’s repolarization liability; Discuss designing a strategy for efficient, rapid and inexpensive assessment of drug-related QT effects; Recognize how to derive an earlier, more robust assessment of a drug’s repolarization effects.
Speaker(s)
Eliminating the E14 TQT: It Is Not If, but When
Charles Benson, MD, PhD
Eli Lilly and Company, United States
Senior Director Clinical Phamacology
New Measures to Differentiate Between Malign and Benign QT Prolongation
David Strauss, MD, PhD
FDA, United States
Director, Division of Applied Regulatory Science, OCP, OTS, CDER
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