C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS › Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products

21 C.F.R. § 320.28

Correlation of bioavailability with an acute pharmacological effect or clinical evidence

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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]
Notes of Decisions
Cited in 1 case, 1985–1985 · leading case: Ciba-Geigy Corp. v. Thompson Med. Co., Inc., 672 F. Supp. 679 (S.D.N.Y. 1985).
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Ciba-Geigy Corp. v. Thompson Med. Co., Inc., 672 F. Supp. 679 (S.D.N.Y. 1985). “And here I quote from 21 C.F.R. § 320.28 (1987): “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.”
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