This meeting will focus on the new direction in the development of pharmaceutical
Agents as well as the 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.
Agents as well as the 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.
