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 combining both analytical and PK similarity evidence: (a) 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) power of the proposed equivalence test in analyzing the Phase 3 data.
