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Table · dataset · 2026

Investigating Heterogeneous Treatment Effects with a Latent Class Mixed Model in Average Bioequivalence

Listed in figshare and Loughborough Research Repository — shown once because both records carry DOI 10.6084/m9.figshare.33324973.v2

<p>Investigating heterogeneity of treatment effects has received a lot of attention in clinical trials, and this is also important in bioequivalence studies.

Description

Average bioequivalence (ABE) using a simple 2× 2 crossover design is currently the most popular method for testing bioequivalence between two drugs, but the heterogeneity issue has been considered as a challenge in performing ABE with 2× 2 crossover design. Considering that factors that can cause heterogeneous treatment effects may not be known a priori or are expensive to measure, we propose to apply the ABE approach based on a latent class mixed model (LCMM), which does not require membership of each subject or the number of subgroups in advance.

Our numerical study shows that the standard linear mixed model result should be carefully interpreted when the proposed method detects the heterogeneous treatment effects.</p>

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Provenance · 2 source records, 31 field assertions
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figshareoai:figshare.com:article/3332497312 d agoJSON v1
Loughborough Research Repositoryoai:figshare.com:article/3332497312 d agoJSON v1
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