CTD Section 4.2.2.5 Report
Summary
Section Name:
Excretion
Section Code:
4.2.2.5
Module Number:
4
Description:
This section focuses on studies where the primary purpose is to assess how the drug or its metabolites are eliminated from the body
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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