Module 5clinicalnda● High priority
5.3.2.2 — Hepatic Metabolism and Drug Interaction
Hepatic metabolism and drug interaction studies using human liver microsomes/hepatocytes
Requirements by Phase
Phase 1
N/A
Phase 2
optional
Phase 3
optional
NDA
required
Hepatic metabolism and drug interaction studies using human liver microsomes/hepatocytes
Requirements by Phase
IND Phase 2: optional IND Phase 3: optional NDA: required
Content Requirements
- Human biomaterial studies on metabolism and drug-drug interactions
- CYP inhibition/induction using human liver microsomes or hepatocytes
- Transporter substrate/inhibitor assessment
- Metabolite profiling in human biomaterials
Expected Deliverables
- Human hepatic metabolism study report
- In vitro DDI study report (human biomaterials)
ICH Guidelines: E3, M4E(R2)
Source: FDA DDI 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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