Federal (United States) · Regulations
Subpart B — Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
18 sections
18 sections
- 21 C.F.R. § 320.21Requirements for submission of bioavailability and bioequivalence data.
- 21 C.F.R. § 320.22Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
- 21 C.F.R. § 320.23Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
- 21 C.F.R. § 320.24Types of evidence to measure bioavailability or establish bioequivalence.
- 21 C.F.R. § 320.25Guidelines for the conduct of an in vivo bioavailability study.
- 21 C.F.R. § 320.26Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
- 21 C.F.R. § 320.27Guidelines on the design of a multiple-dose in vivo bioavailability study.
- 21 C.F.R. § 320.28Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
- 21 C.F.R. § 320.29Analytical methods for an in vivo bioavailability or bioequivalence study.
- 21 C.F.R. § 320.30Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
- 21 C.F.R. § 320.31Applicability of requirements regarding an “Investigational New Drug Application.”
- 21 C.F.R. § 320.32Procedures for establishing or amending a bioequivalence requirement.
- 21 C.F.R. § 320.33Criteria and evidence to assess actual or potential bioequivalence problems.
- 21 C.F.R. § 320.34Requirements for batch testing and certification by the Food and Drug Administration.
- 21 C.F.R. § 320.35Requirements for in vitro testing of each batch.
- 21 C.F.R. § 320.36Requirements for maintenance of records of bioequivalence testing.
- 21 C.F.R. § 320.38Retention of bioavailability samples.
- 21 C.F.R. § 320.63Retention of bioequivalence samples.