Guidelines for conducting bridging studies in Alzheimer disease
N.R. Cutler
Bok Engelsk 1998
| Utgitt | 1998
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|---|---|
| Omfang | Side 88- 92
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| Opplysninger | This report provides guidelines for conducting bridging studies inpatients with Alzheimer disease (AD). Bridging studies are late phaseI safety/tolerance studies that determine the maximum tolerated dose(MTD) in patients before phase LI efficacy studies are initiated,facilitating the transition from phase I to phase II development.Determining the MTD in patients maximizes the potential to detectefficacy by permitting the use of the highest tolerated doses inphase II while providing a good understanding of potential adverseevents. Bridging studies should be double-blind, placebo-controlled,inpatient studies conducted in acute-care facilities by clinicalpersonnel who are equipped to handle unexpected contingencies underthe oversight of a competent, multidisciplinary review board.Patients should be in good physical health (excluding AD), and acomprehensive informed consent procedure must be instituted. Werecommend initially using a fixed-dose panel design with a doseschedule based on the MTD in normal volunteers and later establishingthe dose titration MTD.
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| Emner |
