A bioequivalence test by the direct comparison of concentration-versus-time curves using local polynomial smoothers

DOI10.1155/2016/4680642MaRDI QIDQ2013948zbMATH OpenOpenAlexWikidataFDO

Authors Suyan Tian, Howard H. Chang, Dana Orange, Jingkai Gu, Mayte Suárez Fariñas

Publication date 10 August 2017

Published in Computational \& Mathematical Methods in Medicine (Search for Journal in Brave)

Copyright license Creative Commons Attribution 4.0 International

Full work available at URL https://doi.org/10.1155/2016/4680642

zbMATH Keywords

bioequivalence testlocal polynomial smootherspharmacokinetic parameters

Mathematics Subject Classification ID

Parametric hypothesis testing (62F03) Applications of statistics to biology and medical sciences; meta analysis (62P10) Kinetics in biochemical problems (pharmacokinetics, enzyme kinetics, etc.) (92C45) Medical applications (general) (92C50)

Review text

Summary: In order to test if two chemically or pharmaceutically equivalent products have the same efficacy and/or toxicity, a bioequivalence (BE) study is conducted. The 80\%/125\% rule is the most commonly used criteria for BE and states that BE cannot be claimed unless the 90\% CIs for the ratio of selected pharmacokinetic (PK) parameters of the tested to the reference drug are within 0.8 to 1.25. Considering that estimates of these PK parameters are derived from the concentration-versus-time curves, a direct comparison between these curves motivates an alternative and more flexible approach to test BE. Here, we propose to frame the BE test in terms of an equivalence of concentration-versus-time curves which are constructed using local polynomial smoother (LPS). A metric is presented to quantify the distance between the curves and its 90\% CIs are calculated via bootstrapping. Then, we applied the proposed procedures to data from an animal study and found that BE between a generic drug and its brand name cannot be concluded, which was consistent with the results by applying the 80\%/125\% rule. However, the proposed procedure has the advantage of testing only on a single metric, instead of all PK parameters.

Recommendations

• The multivariate assessment of bioequivalence
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Cites work

• Bandwidth selection: Classical or plug-in?
• Bootstrap methods: another look at the jackknife
• Longitudinal data analysis using generalized linear models
• On equivalence and bioequivalence testing
• Permutation, parametric and bootstrap tests of hypotheses.
• Robust Locally Weighted Regression and Smoothing Scatterplots
• Statistical tests for multivariate bioequivalence
• Variable bandwidth and local linear regression smoothers

Describes a project that uses

Uses Software

• DEseq

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