21 CFR Subpart B
Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
June 25, 2020
§
320.21
Requirements for submission of 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
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