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:
鈥T study design and analyses
鈥he use of new methodologies including concentration-effect modeling
鈥pproaches to QT evaluation in Phase 3 when there is a QT signal
鈥T assessment in patient populations when healthy volunteers cannot be studies
鈥T assessment of biologic compounds
鈥egulatory implications
鈥pecial 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:
鈥T study design and analyses
鈥he use of new methodologies including concentration-effect modeling
鈥pproaches to QT evaluation in Phase 3 when there is a QT signal
鈥T assessment in patient populations when healthy volunteers cannot be studies
鈥T assessment of biologic compounds
鈥egulatory implications
鈥pecial session on the science and clinical ramifications of QT shortening.
