5.3.3.3 — Intrinsic Factor PK Study Reports

PK studies evaluating intrinsic factors (age, sex, race, renal/hepatic impairment, genetic polymorphisms)

Requirements by Phase

IND Phase 3: optional NDA: required

Content Requirements

• Renal impairment PK study
• Hepatic impairment PK study
• Age, gender, race effect on PK
• Genetic polymorphism PK studies (e.g., CYP2D6 poor metabolizers)
• Full CSR per ICH E3 format

Expected Deliverables

• Renal impairment PK study report
• Hepatic impairment PK study report
• Demographic subgroup PK analysis reports
• Pharmacogenomic PK study report (if performed)

ICH Guidelines: E3, M4E(R2)

Source: ICH E5; FDA Guidance