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An alternative index for assessing profile similarity in bioequivalence trials
Author(s) -
Mauger David T.,
Chinchilli Ver M.
Publication year - 2000
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/1097-0258(20001030)19:20<2855::aid-sim550>3.0.co;2-t
Subject(s) - bioequivalence , equivalence (formal languages) , pointwise , smoothing , mathematics , statistics , similarity (geometry) , bioavailability , econometrics , computer science , medicine , pharmacology , artificial intelligence , mathematical analysis , image (mathematics) , discrete mathematics
In a typical bioequivalence trial, summary measures of the plasma concentration versus time profile are used to compare two formulations of a drug product. Commonly used measures include area under the curve (AUC), maximum plasma concentration ( C max ) and time to maximum concentration ( T max ). Equivalence of these summary measures, in general, does not guarantee equivalence of the entire profile. Rescigno and Chinchilli and Elswick propose indices which measure profile similarity, but can be overly sensitive to unimportant differences and are not easily interpreted pharmacologically. We propose an alternative index based on smoothing the relative difference between bioavailability profiles. This provides a method for assessing bioequivalence over the entire profile which has a familiar interpretation and can be tuned to provide a compromise between the insensitivity to pattern differences of summary measures and the oversensitivity of pointwise comparisons. Copyright © 2000 John Wiley & Sons, Ltd.