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Pharmaceutical Research

, Volume 9, Issue 7, pp 925–928 | Cite as

Bioequivalence

  • Aldo Rescigno
Article

Abstract

The bioequivalence of two formulations of the same drug may be determined by evaluating the similarity of their respective plasma concentration curves. The similarity of two plasma concentration functions can be measured by an index called the bioequivalence index. This paper shows how such an index may be defined and calculated.

bioequivalence bioavailability plasma concentration function AUG 

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REFERENCES

  1. 1.
    U.S. Food and Drug Administration. Bioavailability and bioequivalence requirements. Fed. Regist. 42:1638–1653 (1977).Google Scholar
  2. 2.
    C. M. Metzler. Bioavailability—a problem in equivalence. Biometrics 30:309–317 (1974).Google Scholar
  3. 3.
    C. M. Metzler. Equivalence of bioavailability and efficacy in drug testing. In A. Pecile and A. Rescigno (eds.), Pharmacokinetics: Mathematical and Statistical Approaches to Metabolism and Distribution of Chemicals and Drugs, Plenum Press, New York, 1988, pp. 215–225.Google Scholar

Copyright information

© Plenum Publishing Corporation 1992

Authors and Affiliations

  • Aldo Rescigno
    • 1
    • 2
  1. 1.School of PharmacyUniversity of ParmaItaly
  2. 2.Department of PharmacokineticsGenentech, Inc.South San Francisco

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