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

Title 21Chapter ISubchapter DPart 320Subpart B → §320.29


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


§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 §320.31 are met.

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

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