CTD Section 4.2.2.7 Report
Summary
Section Name:
Other Pharmacokinetic Studies
Section Code:
4.2.2.7
Module Number:
4
Description:
This section should include all studies where the primary purpose was to assess pharmacokinetics beyond simple ADME or drug interactions. This could include studies conducted in special populations, or studies investigating pharmacogenomic considerations.
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