Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Simulation results for using the analytical assessment evidence in both designing and analyzing the Phase 3 study: (a) and (c) show the ratio of the sample sizes in the Phase 3 study to achieve the power of 80% when the prior evidence is used versus when it is not used; and (b) and (d) show the power of the proposed equivalence test in analyzing the Phase 3 data.
