CTD Section 4.2.3.1 Report
Summary
Section Name:
Single-Dose Toxicity (in order by species, by route)
Section Code:
4.2.3.1
Module Number:
4
Description:
This section should include all studies where the primary purpose was to assess potential short-term toxic effects of new drugs, to establish maximum tolerated dose, identify organs that are susceptible to toxicity, or to establish safety margins
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