机译:Statistical Consideration and Challenges in Bridging Study of Personalized Medicine
US FDA, Div Biostat, Ctr Devices & Radiol Hlth, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA;
Companion diagnostic assay; Clinical trial assay; Personalized medicine; Drug efficacy; Bridging study; Device-drug pivotal clinical trial; Device's intended use population;