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A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers
Joint Authors
Tian, Suyan
Chang, Howard H.
Orange, Dana
Gu, Jingkai
Suárez-Fariñas, Mayte
Source
Computational and Mathematical Methods in Medicine
Issue
Vol. 2016, Issue 2016 (31 Dec. 2016), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2016-12-05
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Abstract EN
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 pharmacokinetics (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.
American Psychological Association (APA)
Tian, Suyan& Chang, Howard H.& Orange, Dana& Gu, Jingkai& Suárez-Fariñas, Mayte. 2016. A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers. Computational and Mathematical Methods in Medicine،Vol. 2016, no. 2016, pp.1-6.
https://search.emarefa.net/detail/BIM-1100136
Modern Language Association (MLA)
Tian, Suyan…[et al.]. A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers. Computational and Mathematical Methods in Medicine No. 2016 (2016), pp.1-6.
https://search.emarefa.net/detail/BIM-1100136
American Medical Association (AMA)
Tian, Suyan& Chang, Howard H.& Orange, Dana& Gu, Jingkai& Suárez-Fariñas, Mayte. A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers. Computational and Mathematical Methods in Medicine. 2016. Vol. 2016, no. 2016, pp.1-6.
https://search.emarefa.net/detail/BIM-1100136
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1100136