CTD Section 5.3.1.1 Report
Summary
Section Name:
Bioavailability (BA) Study Reports
Section Code:
5.3.1.1
Module Number:
5
Description:
Studies in which the primary purpose is to evaluate the rate and extent of release of the active substance from the medicinal product
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