CTD Section 5.3.1.2 Report
Summary
Section Name:
Comparative BA and Bioequivalence (BE) Study Reports
Section Code:
5.3.1.2
Module Number:
5
Description:
Studies in which the primary purpose is to compare the rate and extent of release of the drug substance from similar drug products
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources