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