Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 320
8. ›
9. Subpart B

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 320.21
  § 320.21 Requirements for submission of bioavailability and bioequivalence data.
• 320.22
  § 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
• 320.23
  § 320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
• 320.24
  § 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
• 320.25
  § 320.25 Guidelines for the conduct of an in vivo bioavailability study.
• 320.26
  § 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
• 320.27
  § 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.
• 320.28
  § 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
• 320.29
  § 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
• 320.30
  § 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
• 320.31
  § 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
• 320.32
  § 320.32 Procedures for establishing or amending a bioequivalence requirement.
• 320.33
  § 320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
• 320.34
  § 320.34 Requirements for batch testing and certification by the Food and Drug Administration.
• 320.35
  § 320.35 Requirements for in vitro testing of each batch.
• 320.36
  § 320.36 Requirements for maintenance of records of bioequivalence testing.
• 320.38
  § 320.38 Retention of bioavailability samples.
• 320.63
  § 320.63 Retention of bioequivalence samples.