Title 21

PART 320

Part 320 - Bioavailability And Bioequivalence Requirements

PART 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Authority:21 U.S.C. 321, 351, 352, 355, 371.

• Authority: 21 U.S.C. 321, 351, 352, 355, 371.

21:5.0.1.1.8.1	SUBPART A	Subpart A - General Provisions
21:5.0.1.1.8.1.1.1	SECTION 320.1	320.1 Definitions.
21:5.0.1.1.8.2	SUBPART B	Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
21:5.0.1.1.8.2.1.1	SECTION 320.21	320.21 Requirements for submission of bioavailability and bioequivalence data.
21:5.0.1.1.8.2.1.2	SECTION 320.22	320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
21:5.0.1.1.8.2.1.3	SECTION 320.23	320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
21:5.0.1.1.8.2.1.4	SECTION 320.24	320.24 Types of evidence to measure bioavailability or establish bioequivalence.
21:5.0.1.1.8.2.1.5	SECTION 320.25	320.25 Guidelines for the conduct of an in vivo bioavailability study.
21:5.0.1.1.8.2.1.6	SECTION 320.26	320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
21:5.0.1.1.8.2.1.7	SECTION 320.27	320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.
21:5.0.1.1.8.2.1.8	SECTION 320.28	320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
21:5.0.1.1.8.2.1.9	SECTION 320.29	320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
21:5.0.1.1.8.2.1.10	SECTION 320.30	320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
21:5.0.1.1.8.2.1.11	SECTION 320.31	320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
21:5.0.1.1.8.2.1.12	SECTION 320.32	320.32 Procedures for establishing or amending a bioequivalence requirement.
21:5.0.1.1.8.2.1.13	SECTION 320.33	320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
21:5.0.1.1.8.2.1.14	SECTION 320.34	320.34 Requirements for batch testing and certification by the Food and Drug Administration.
21:5.0.1.1.8.2.1.15	SECTION 320.35	320.35 Requirements for in vitro testing of each batch.
21:5.0.1.1.8.2.1.16	SECTION 320.36	320.36 Requirements for maintenance of records of bioequivalence testing.
21:5.0.1.1.8.2.1.17	SECTION 320.38	320.38 Retention of bioavailability samples.
21:5.0.1.1.8.2.1.18	SECTION 320.63	320.63 Retention of bioequivalence samples.

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