What 21 CFR Part 320 - Bioavailability and Bioequivalence Requirements (FDA) requires
FDA 21 CFR Part 320 sets the bioavailability and bioequivalence requirements for drug products, requiring applicants to submit the required data, apply the waiver criteria where appropriate, establish the basis for measuring in vivo bioavailability or demonstrating bioequivalence, select the types of evidence, follow the guidelines for designing and conducting single-dose and multiple-dose in vivo studies, validate the analytical methods, meet the applicable Investigational New Drug requirements, follow the procedures for establishing or amending a bioequivalence requirement, carry out batch and in vitro testing where required, and retain the records and samples.
Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-320
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Primary Citations — 17 traced to source
- 21 CFR § 320.1 - Definitions
- 21 CFR § 320.21 - Requirements for submission of bioavailability and bioequivalence data
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