CTD Section 4.2.3.7.5 Report
Summary
Section Name:
Metabolites
Section Code:
4.2.3.7.5
Module Number:
4
Description:
These studies assess the potential for a drug's metabolites to cause adverse effects
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