CTD Section 5.3.1.3 Report
Summary
Section Name:
In Vitro-In Vivo Correlation Study Reports
Section Code:
5.3.1.3
Module Number:
5
Description:
In vitro dissolution studies that provide BA information, or correlate in vitro data with in vivo correlations
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