CFR /  Title 21  /  Part 320: Bioavailability And Bioequivalence Requirements

Section No.	Description
Section 320.1	Requirements for submission of bioavailability and bioequivalence data
Section 320.21	Criteria for waiver of evidence of in vivo bioavailability or bioequivalence
Section 320.22	Basis for measuring in vivo bioavailability or demonstrating bioequivalence
Section 320.23	Types of evidence to measure bioavailability or establish bioequivalence
Section 320.24	Guidelines for the conduct of an in vivo bioavailability study
Section 320.25	Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study
Section 320.26	Guidelines on the design of a multiple-dose in vivo bioavailability study
Section 320.27	Correlation of bioavailability with an acute pharmacological effect or clinical evidence
Section 320.28	Analytical methods for an in vivo bioavailability or bioequivalence study
Section 320.29	Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration
Section 320.30	Applicability of requirements regarding an ``Investigational New Drug Application
Section 320.31	Procedures for establishing or amending a bioequivalence requirement
Section 320.32	Criteria and evidence to assess actual or potential bioequivalence problems
Section 320.33	Requirements for batch testing and certification by the Food and Drug Administration
Section 320.34	Requirements for in vitro testing of each batch
Section 320.35	Requirements for maintenance of records of bioequivalence testing
Section 320.36	Retention of bioavailability samples
Section 320.38	Retention of bioequivalence samples
Section 320.63	Scope