CTD Section 4.2.3.7.1 Report
Summary
Section Name:
Antigenicity
Section Code:
4.2.3.7.1
Module Number:
4
Description:
These studies assess the potential for a drug to bind to antibodies or T-cell receptors
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