DIA 2013 49th Annual Meeting
Click here to go to the previous page
The Thorough QT Study: Isn't There a Better Way to Do This?
Track : Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code: 205
Date: Tuesday, June 25, 2013
Time: 8:00 AM to 9:30 AM  EST
Location: 105
CHAIR :
 Charles Benson, MD,PhD (SCHNON), Medical Fellow, Eli Lilly and Company, United States
SPEAKER (S):
 Charles Benson, MD,PhD (SPKNON), Medical Fellow, Eli Lilly and Company, United States
 Jay W. Mason, MD (SPKNON), Chief Medical Officer, Spaulding Clinical Research, United States
David Strauss, MD,PhD (SPKAGY), Medical Officer, Office of Science and Engineering Laboratories, CDRH, FDA, United States
Description
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.