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Part 320
FEDERAL · 21 CFR
Part 320 — Bioavailability and Bioequivalence Requirements
19 sections · Title 21: Food and Drugs
§ 320.1
Definitions.
§ 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.