CTD Section 5.3.3.2 Report
Summary
Section Name:
Patient PK and Initial Tolerability Study Reports
Section Code:
5.3.3.2
Module Number:
5
Description:
PK reports in patients should be placed here for drugs
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