Standard Article

Bioequivalence

  1. Laszlo Endrenyi

Published Online: 15 JUL 2005

DOI: 10.1002/0470011815.b2a04003

Encyclopedia of Biostatistics

Encyclopedia of Biostatistics

How to Cite

Endrenyi, L. 2005. Bioequivalence. Encyclopedia of Biostatistics. 1.

Author Information

  1. University of Toronto, Toronto, Ontario, Canada

Publication History

  1. Published Online: 15 JUL 2005

Abstract

Bioequivalence is defined as the comparable bioavailability of alternative drug formulations. Kinetic measures of bioavailability are reviewed, leading to a discussion of the statistical assessment of bioequivalence. Parametric and nonparametric methods of testing are described. Current research areas including the estimation of individual bioequivalence and alternative measures for the evaluation of bioequivalence are reviewed.

Keywords:

  • bioavailability;
  • kinetic measures;
  • area under the curve (AUC);
  • individual bioequivalence