CTD Section 5.3.3.5 Report
Summary
Section Name:
Population PK Study Reports
Section Code:
5.3.3.5
Module Number:
5
Description:
Studies assessing PK in sparse samples obtained from larger groups (e.g. Phase 3, postmarketing) can be placed here since they usually employ substantially different methods
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