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e-CFR data is current as of July 6, 2020

Title 21Chapter ISubchapter DPart 320Subpart B → §320.28


Title 21: Food and Drugs
PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products


§320.28   Correlation of bioavailability with an acute pharmacological effect or clinical evidence.

Correlation of in vivo bioavailability data with an acute pharmacological effect or clinical evidence of safety and effectiveness may be required if needed to establish the clinical significance of a special claim, e.g., in the case of an extended release preparation.

[42 FR 1648, Jan. 7, 1977, as amended at 67 FR 77674, Dec. 19, 2002]

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