CTD Section 5.3.1.4 Report
Summary
Section Name:
Reports of Bioanalytical and Analytical Methods for Human Studies
Section Code:
5.3.1.4
Module Number:
5
Description:
For methods used in multiple studies, place a report on the method and its validation in this section, and reference in the appropriate individual study reports
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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