QT Issues in Drug Development the evolving science, practical issues, and regulatory implications

Venue: Washington Marriott Hotel

Location: Washington, District Of Columbia, United States

Event Date/Time: Apr 11, 2007 End Date/Time: Apr 13, 2007
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This program will bring together a faculty of regulatory, industry, and scientific leaders in the field to explore and discuss the evolving science surrounding drug development and cardiac repolarization. The meeting will focus on the current state of the art, new directions that can meaningfully impact the development of pharmaceutical agents, and practical challenges and possible solutions. Specific areas of concentration will include:
•QT study design and analyses
•the use of new methodologies including concentration-effect modeling
•approaches to QT evaluation in Phase 3 when there is a QT signal
•QT assessment in patient populations when healthy volunteers cannot be studies
•QT assessment of biologic compounds
•regulatory implications
•Special session on the science and clinical ramifications of QT shortening.


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United States