CTD Section 5.3.2.2 Report
Summary
Section Name:
Reports of Hepatic Metabolism and Drug Interaction Studies
Section Code:
5.3.2.2
Module Number:
5
Description:
Use this section for studies of hepatic metabolism and metabolic drug interactions using human hepatic tissue
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