CTD Section 4.2.2.3 Report
Summary
Section Name:
Distribution
Section Code:
4.2.2.3
Module Number:
4
Description:
This section focuses on studies where the primary purpose is to assess how the drug travels through the bloodstream and reaches the target tissue or other non-target tissues
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