CTD Section 5.3.3.3 Report
Summary
Section Name:
Intrinsic Factor PK Study Reports
Section Code:
5.3.3.3
Module Number:
5
Description:
Studies to assess the effects of intrinsic (age, gender, race, weight, height, genetic polymorphism, organ dysfunction) factors should be placed here
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