5.3.1.1 — Bioavailability Study Reports

Reports of absolute and relative bioavailability studies

Requirements by Phase

IND Phase 3: optional NDA: required

Content Requirements

• Absolute and relative bioavailability study reports
• Full CSR per ICH E3 format
• PK parameters (AUC, Cmax, Tmax, t1/2, F)
• Statistical analysis of BA parameters

Expected Deliverables

• Bioavailability study report (ICH E3 format)

ICH Guidelines: E3, M4E(R2)

Regulatory Requirements (ICH Q6A)

• [Marketing Approval] Particle size testing for particle size distribution should be carried out using an appropriate procedure with acceptance criteria for new drug substances intended for use in solid or suspension drug products where particle size significantly affects dissolution rates, bioavailability, and/or stability.
• [Marketing Approval] If different crystalline forms (polymorphism, solvation/hydration products, amorphous forms) of a new drug substance exist and affect drug product performance, bioavailability, or stability, the appropriate solid state should be specified.
• [Marketing Approval] For immediate-release drug products where changes in dissolution rate significantly affect bioavailability, test conditions should distinguish batches with unacceptable bioavailability.

Source: ICH M4E