[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR320.28]

[Page 195]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS--Table of Contents
 
      Subpart B--Procedures for Determining the Bioavailability or 
                     Bioequivalence of Drug Products
 
Sec. 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 a controlled release preparation.