CTD Section 5.3.2.1 Report
Summary
Section Name:
Plasma Protein Binding Study Reports
Section Code:
5.3.2.1
Module Number:
5
Description:
Use this section for ex vivo protein binding study reports
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