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21 C.F.R. PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Subpart A--GENERAL PROVISIONS

�320.1

Definitions.

Subpart B--PROCEDURES FOR DETERMINING THE BIOAVAILABILITY OR BIOEQUIVALENCE OF DRUG PRODUCTS

�320.21

Requirements for submission of in vivo 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.