CTD Section 2.7.2 Report
Summary
Section Name:
Summary of Clinical Pharmacology Studies
Section Code:
2.7.2
Module Number:
2
Description:
This section should provide the reviewer with an overall view of the clinical pharmacology studies performed to evaluate human pharmacokinetics and pharmacodynamics, and any studies performed with human biomaterials that are pertinent to PK processes
Submission Timing
As early as initial IND application (see note), completed by marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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