21 CFR Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products

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  1. § 320.21 Requirements for submission of bioavailability and bioequivalence data.
  2. § 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
  3. § 320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
  4. § 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
  5. § 320.25 Guidelines for the conduct of an in vivo bioavailability study.
  6. § 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
  7. § 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.
  8. § 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
  9. § 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
  10. § 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
  11. § 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
  12. § 320.32 Procedures for establishing or amending a bioequivalence requirement.
  13. § 320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
  14. § 320.34 Requirements for batch testing and certification by the Food and Drug Administration.
  15. § 320.35 Requirements for in vitro testing of each batch.
  16. § 320.36 Requirements for maintenance of records of bioequivalence testing.
  17. § 320.38 Retention of bioavailability samples.
  18. § 320.63 Retention of bioequivalence samples.
Source:
42 FR 1648, Jan. 7, 1977, unless otherwise noted.