CTD Section 4.2.3.3.2 Report
Summary
Section Name:
In vivo (including supportive toxicokinetics evaluations)
Section Code:
4.2.3.3.2
Module Number:
4
Description:
Studies conducted in vivo (mammalian system) that assess genetic damage caused by drug, may also be evaluated with tumorigenicity
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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