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.

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