Correlation of in vivo bioavailability data with an acute pharmacological effect or clinical evidence of safety and effectiveness may be required if needed to establish the clinical significance of a special claim, e.g., in the case of an extended release preparation.
21 CFR Part 320 · Bioavailability and Bioequivalence Requirements
§ 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence
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Amendment history
Federal Register documents that created or amended this section.
- 42 FR 1648 7 Jan 1977
- 67 FR 77674 19 Dec 2002