5.3.1.2 — Comparative BA/BE Study Reports

Reports of comparative bioavailability and bioequivalence studies

Requirements by Phase

IND Phase 3: optional NDA: required

Content Requirements

• Comparative bioavailability and bioequivalence study reports
• Full CSR per ICH E3 format
• 90% CI for Cmax and AUC ratios
• Formulation comparisons

Expected Deliverables

• Comparative BA/BE study report (ICH E3 format)

ICH Guidelines: E3, M4E(R2)

Regulatory Requirements (ICH Q6A)

• [Marketing Approval] For extended-release drug products, acceptance criteria should be established based on available batch data, with permitted variability in mean release rate not exceeding a total numerical difference of +/-10% of labeled content, unless a wider range is supported by a bioequivalency study.

Source: ICH M4E