CTD Section 4.2.2.6 Report
Summary
Section Name:
Pharmacokinetic Drug Interactions
Section Code:
4.2.2.6
Module Number:
4
Description:
This section should include all studies where the primary purpose was to find or characterize potential drug-drug interactions that impact ADME of the drug
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