Module 5clinicalnda● High priority
5.3.3.4 — Extrinsic Factor PK Study Reports
PK studies evaluating extrinsic factors (drug interactions, food, smoking)
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
optional
NDA
required
PK studies evaluating extrinsic factors (drug interactions, food, smoking)
Requirements by Phase
IND Phase 3: optional NDA: required
Content Requirements
- Drug-drug interaction clinical studies
- Food effect PK studies
- Formulation effect PK studies
- Full CSR per ICH E3 format
Expected Deliverables
- Clinical DDI study report(s) (ICH E3 format)
- Food effect study report
- Formulation PK study report (if applicable)
ICH Guidelines: E3, M4E(R2)
Source: FDA DDI Guidance; FDA Food-Effect Guidance
References
Related Sections
Up to5.3 — Clinical Study Reports5.3.1 — Reports of Biopharmaceutic Studies
5.3.1.1 — Bioavailability Study Reports
Reports of absolute and relative bioavailability studies
5.3.1.2 — Comparative BA/BE Study Reports
Reports of comparative bioavailability and bioequivalence studies
5.3.1.3 — In Vitro–In Vivo Correlation Reports
Reports correlating in vitro dissolution to in vivo bioavailability
5.3.1.4 — Bioanalytical and Analytical Methods
Validation reports for bioanalytical methods used in human studies
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