[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR320.28]

[Page 194]
 
                        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 extended release preparation.

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