A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers

المؤلفون المشاركون

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

المصدر

Computational and Mathematical Methods in Medicine

العدد

المجلد 2016، العدد 2016 (31 ديسمبر/كانون الأول 2016)، ص ص. 1-6، 6ص.

الناشر

Hindawi Publishing Corporation

تاريخ النشر

2016-12-05

دولة النشر

مصر

عدد الصفحات

6

التخصصات الرئيسية

الطب البشري

الملخص 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.

نمط استشهاد جمعية علماء النفس الأمريكية (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

نمط استشهاد الجمعية الأمريكية للغات الحديثة (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

نمط استشهاد الجمعية الطبية الأمريكية (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

نوع البيانات

مقالات

لغة النص

الإنجليزية

الملاحظات

Includes bibliographical references

رقم السجل

BIM-1100136