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Biometrika 1993 80(4):835-846; doi:10.1093/biomet/80.4.835
© 1993 by Biometrika Trust
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Moment-based criteria for determining bioequivalence

DANIEL J. HOLDER and FRANCIS HSUAN

Merck Research Laboratories West Point, Pennsylvania, 19486, U.S.A.
Department of Statistics, Temple University Philadelphia, Pennsylvania, 19122, U.S.A.

In comparative bioavailability trials, the focus in the determination of bioequivalence has been to show that the average bioavailability on a test formulation is similar to the average bioavailability on a reference formulation. It has been argued that this is not adequate to insure interchangeability of formulations. We introduce a moment-based criterion which ensures interchangeability for at least a certain proportion of the population. An algorithm is given for determining the constant in the criterion. An example is used to illustrate how the criterion may be applied.

Key Words: Bioequivalence • Individual bioequivalence • Interaction • Interchangeability • Mixed-effects model • Variance components


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