Sankhya: The Indian Journal of Statistics

2000, Volume 62, Series B, Pt. 1, 149--161

PROFILE SIMILARITY IN BIOEQUIVALENCE TRIALS

By

DAVID T. MAUGER,

and

VERNON M. CHINCHILLI, The Pennsylvania State University, Hershey

SUMMARY.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 (Cmax) and time to maximum concentration (Tmax). Equivalence of these summary measures, in general, does not guarantee equivalence of the entire profile. Rescigno (1992) and Chinchilli and Elswick (1997) propose summary statistics which measure profile similarity, but are not easily interpreted pharmacologically. We propose a method for assessing bioequivalence over the entire profile which has a familiar interpretation and represents a compromise between the insensitivity to pattern differences of summary measures and the oversensitivity of pointwise comparisons.

AMS (1991) subject classification. 92B15, 62P10

Key words and phrases. Bioequivalence, bioavailability, AUC.

Full paper (PDF)

This article in Mathematical Reviews