CTD Section 4.2.2.1 Report
Summary
Section Name:
Analytical Methods and Validation Reports
Section Code:
4.2.2.1
Module Number:
4
Description:
This section contains comprehensive descriptions of novel methods used in assessments of drugs, their metabolites, and biomarkers, as well as validation data demonstrating the assay is fit for purpose
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