CTD Section 4.2.3.2 Report
Summary
Section Name:
Repeat-Dose Toxicity (species, route, duration, including supportive toxicokinetics)
Section Code:
4.2.3.2
Module Number:
4
Description:
This section should include all studies where the primary purpose was to assess potential long-term toxic effects of new drugs, to identify dose-limiting factors, and evaluate reversibility of toxic 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
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