DIA 48th Annual Meeting
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Drug QT Derisking: Changes in When and How
Track : Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code: 157
Date: Monday, June 25, 2012
Time: 3:30 PM to 5:00 PM  EST
CHAIR :
 William Wheeler, Wheeler Biopharm Consulting, LLC, United States
PRESENTER (S):
 William Wheeler, Wheeler Biopharm Consulting, LLC, United States
 Royce Morrison, Comprehensive Clinical Development, United States
 Gary Gintant, Abbott Laboratories, United States
Description
QT "derisking," mandated for all drugs, has become simpler and inexpensive to confidently achieve in early-phase clinical studies. Learn how to acquire continuous ECG data with small N and analyze by methods translated from preclinical to human.

Learning Objectives:
Discuss the safety and regulatory imperatives for cardiac safety studies
Identify the need for research/analytic methods that translate across preclinical and clinical development
Explain how to better choose the available options for when and how to "derisk" a drug in development.