Part 320 — Bioavailability and Bioequivalence Requirements
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 355, 371.
Sections
- § 320.1 Definitions.
- § 320.21 Requirements for submission of bioavailability and bioequivalence data.
- § 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
- § 320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
- § 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
- § 320.25 Guidelines for the conduct of an in vivo bioavailability study.
- § 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
- § 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.
- § 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
- § 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
- § 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
- § 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
- § 320.32 Procedures for establishing or amending a bioequivalence requirement.
- § 320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
- § 320.34 Requirements for batch testing and certification by the Food and Drug Administration.
- § 320.35 Requirements for in vitro testing of each batch.
- § 320.36 Requirements for maintenance of records of bioequivalence testing.
- § 320.38 Retention of bioavailability samples.
- § 320.63 Retention of bioequivalence samples.