Iterated bootstrap procedure in individual bioequivalence

Ufuk Beyaztas

doi:10.31801/cfsuasmas.438407

Abstract

In this paper, we propose an iterating principle in the bootstrap method to assess the individual bioequivalence under 2×4 randomized crossover design. The finite sample properties of the proposed algorithm are illustrated by an extensive simulation study and a real-world example. Our findings reveal that the proposed idea have better performance than the classical percentile bootstrap confidence limits.

Highlights

Bioequivalence (BE) studies play an important role in the drug development process
We propose to use iterated bootstrap algorithm to test the individual bioequivalence hypothesis under 2 4 randomized crossover design, and we compare their performances with the conventional bootstrap methods both by simulations and a case study
The important result produced by iterated bootstrap algorithm is that the power of the test obtained by this method are signi...cantly better than those obtained by classical bootstrap methods

Summary

Introduction

Bioequivalence (BE) studies play an important role in the drug development process. The goal of such studies is to evaluate the therapeutic equivalence of two (or more) drugs or to study if two di¤erent galenic formulations of the same drug have a similar bioavailability and therapeutic e¤ect. A formal de...nition of the BE given by [4] is as follows: “Bioequivalence is de...ned as the absence of a signi...cant di¤erence in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." Usually, the BE studies are carried out by measuring the drug concentration in the blood by several pharmacokinetic variables. Note that the BE studies are performed with healthy volunteer subjects

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