21 CFR Part 320 — Bioavailability and Bioequivalence Requirements
Subpart A — General Provisions
Subpart B — Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
- § 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.