CTD Section 3.2.P.4.2 Report
Summary
Section Name:
Analytical Procedures
Section Code:
3.2.P.4.2
Module Number:
3
Description:
Provide a description of the anlytical procedures used to test novel excipients. If your manufacturer is performing additional testing on compendial excipients, describe that here.
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources