21 CFR 320.29: Analytical methods for an in vivo bioavailability or bioequivalence study
Requires that analytical methods in in vivo bioavailability or bioequivalence studies be shown accurate, precise, and sensitive enough to measure actual drug or active metabolite concentrations, allowing multiple single doses together when sensitivity is inadequate and other requirements are met.
Part 320, Bioavailability and Bioequivalence Requirements · Subpart B, Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
Recent 483s citing 320.29
- SGS France Life Sciences · Saint Benoit, Cedex, FranceAug 29, 2025
- ICON PLC · Lenexa, Kansas1-In study ^^ for the the firm used calibration standards and QC samples outside… Jun 13, 2025
- Cetero Research · Houston, TexasStability was not demonstrated under the same conditions as in the study samples… Dec 10, 2010
The regulation text
§ 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]
Questions
What does 21 CFR 320.29 require?
Requires that analytical methods in in vivo bioavailability or bioequivalence studies be shown accurate, precise, and sensitive enough to measure actual drug or active metabolite concentrations, allowing multiple single doses together when sensitivity is inadequate and other requirements are met.