[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR320.29]

[Page 195]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 320_BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS--
Table of Contents
 
      Subpart B_Procedures for Determining the Bioavailability or 
                     Bioequivalence of Drug Products
 
Sec. 320.29  Analytical methods for an in vivo bioavailability
or bioequivalence study.

    (a) The analytical method used in an in vivo bioavailability or 
bioequivalence study to measure the concentration of the active drug 
ingredient or therapeutic moiety, or its active metabolite(s), in body 
fluids or excretory products, or the method used to measure an acute 
pharmacological effect shall be demonstrated to be accurate and of 
sufficient sensitivity to measure, with appropriate precision, the 
actual concentration of the active drug ingredient or therapeutic 
moiety, or its active metabolite(s), achieved in the body.
    (b) When the analytical method is not sensitive enough to measure 
accurately the concentration of the active drug ingredient or 
therapeutic moiety, or its active metabolite(s), in body fluids or 
excretory products produced by a single dose of the test product, two or 
more single doses may be given together to produce higher concentration 
if the requirements of Sec. 320.31 are met.

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