A Related Problem in Bioavailability/Bioequivalence Studies — Estimation of the Intrasubject Variability With a Common CV

Abstract

AbstractThe problem of characterizing the intrasubject variability in bioavailability/bioequivalence studies when the intrasubject variability differs from subject to subject is considered. To account for the heterogeneity of the intrasubject variability, a conditional random effects model that assumes a common coefficient of variation (CV) for each subject is proposed. This common CV is used to assess the intrasubject variability. Several procedures are developed for estimating the common CV. The proposed estimators are compared asymptotically. An extensive simulation study is conducted to study their finite sample performances.