Individual Bioequivalence with Multivariate Approach.

Abdur Rasheed; Junaid Saghir Siddiqi; Tasneem Ahmad

Author(s)

Abdur Rasheed Department of Statistics, University of Karachi, Karachi, Pakistan

Junaid Saghir Siddiqi Department of Statistics, University of Karachi, Karachi, Pakistan

Tasneem Ahmad Ex-Chairman and Prof. of Pharmaceutics, University of Karachi, Pakistan

Abstract

This research proposes a multivariate generalization of the criterion used for testing individual bioequivalence. Although various approaches have been reported in literature for multivariate equivalence, majority of these contemplate simultaneous comparisons of means in each dimension for multivariate equivalence region. Unlike previous approaches, our proposed criterion combines not only the comparison of means and variances but also the within-subject correlations into a single aggregate criterion. The exact distribution of proposed criterion is not traceable, therefore, bootstrap method as recommended by FDA is proposed. The performance of our multivariate individual bioequivalence criterion has been evaluated through a simulation study. The power and size of the study using multivariate individual bioequivalence criterion are determined by varying sample sizes, mean differences, within-subject variances as well as withinsubject correlations between pharmacokinetic parameters.

Publication Details

Page(s) 371-391

DOI DOI not available

Published Journal: Pakistan Journal of Statistics, Volume: 32, Issue: 5, Year: 2016

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