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Activity Number: 261
Type: Topic Contributed
Date/Time: Tuesday, August 5, 2008 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistical Graphics
Abstract - #301486
Title: Graphical Exploration for Cardiovascular Safety Data in Clinical Trials
Author(s): Ihab G. Girgis*+ and Surya Mohanty
Companies: Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC
Address: Advanced Modeling & Simulation, Raritan, NJ, 08869,
Keywords:
Abstract:

Detecting drug-induced effect on cardiac repolarization or QT interval is a closely monitored safety element in drug development and more recently, it is thoroughly scrutinized in regulatory submissions. This work focuses on the graphical representation of the exploration and the modeling of baseline QT clinical data.

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Revised September, 2008