What US 21 CFR Part 320: Bioavailability and Bioequivalence Requirements requires
US 21 CFR Part 320 sets the requirements for demonstrating bioavailability (BA) and bioequivalence (BE) for drug products submitted under NDA, ANDA, INDs, and supplements…
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Pillar: Pharmaceuticals & Life Sciences · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-320
SHA-256 integrity: 31e9c628164330bb5142377010da0d6dc34801c86d882b43fb9d9b0a03c3a85a
Primary Citations — 5 traced to source
- Title 21 Code of Federal Regulations Bioavailability and Bioequivalence Requirements
- Title 21 Code of Federal Regulations Applications for FDA Approval to Market a New Drug
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