Code · CFR · Title 21 — Food and Drugs · Part 320 — Bioavailability and Bioequivalence Requirements · § 320.28

§ 320.28. Correlation of bioavailability with an acute pharmacological effect or clinical evidence.

56 words·~1 min read·/us/cfr/t21/s§ 320.28

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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