Title 21, Part 320 — Bioavailability and Bioequivalence Requirements

Definitions.

Requirements for submission of bioavailability and bioequivalence data.

Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

Basis for measuring in vivo bioavailability or demonstrating bioequivalence.

Types of evidence to measure bioavailability or establish bioequivalence.

Guidelines for the conduct of an in vivo bioavailability study.

Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

Guidelines on the design of a multiple-dose in vivo bioavailability study.

Correlation of bioavailability with an acute pharmacological effect or clinical evidence.

Analytical methods for an in vivo bioavailability or bioequivalence study.

Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.

Applicability of requirements regarding an “Investigational New Drug Application.”

Procedures for establishing or amending a bioequivalence requirement.

Criteria and evidence to assess actual or potential bioequivalence problems.

Requirements for batch testing and certification by the Food and Drug Administration.

Requirements for in vitro testing of each batch.

Requirements for maintenance of records of bioequivalence testing.

Retention of bioavailability samples.

Retention of bioequivalence samples.