CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS > SUBPART B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products (§320.21 to §320.63) > 320.28—Correlation of bioavailability with an acute pharmacological effect or clinical evidence.

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.

Code of Federal Regulations

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