SUBPART B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products (§320.21 to §320.63)
- 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.