New approach to assess bioequivalence parameters using generalized gamma mixed-effect model (model-based asymptotic bioequivalence test)

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題名:	New approach to assess bioequivalence parameters using generalized gamma mixed-effect model (model-based asymptotic bioequivalence test)
作者:	陳玉英;Chen, Yuh-Ing;Huang, Chi-Shen
貢獻者:	太空科學與科技研究中心
關鍵詞:	Algorithms;Benzbromarone - pharmacokinetics;bioequivalence test;Ciprofloxacin - blood;Ciprofloxacin - pharmacokinetics;Computer Simulation;Cross-Over Studies;crossover design;Drugs;Humans;Male;Mathematical models;Medical statistics;mixed-effects model;Models, Statistical;Monte Carlo Method;Monte Carlo simulation;Multivariate Analysis;multivariate generalized gamma distribution;Therapeutic Equivalency;Uric Acid - urine
日期:	2014-02-28
上傳時間:	2026-04-23 11:03:37 (UTC+8)
出版者:	John Wiley and Sons Ltd;England: Blackwell Publishing Ltd
摘要:	摘要： In the pharmacokinetic (PK) study under a 2x2 crossover design that involves both the test and reference drugs, we propose a mixed‐effects model for the drug concentration‐time profiles obtained from subjects who receive different drugs at different periods. In the proposed model, the drug concentrations repeatedly measured from the same subject at different time points are distributed according to a multivariate generalized gamma distribution, and the drug concentration‐time profiles are described by a compartmental PK model with between‐subject and within‐subject variations. We then suggest a bioequivalence test based on the estimated bioavailability parameters in the proposed mixed‐effects model. The results of a Monte Carlo study further show that the proposed model‐based bioequivalence test is not only better on maintaining its level but also more powerful for detecting the bioequivalence of the two drugs than the conventional bioequivalence test based on a non‐compartmental analysis or the one based on a mixed‐effects model with a normal error variable. The application of the proposed model and test is finally illustrated by using data sets in two PK studies. Copyright © 2013 John Wiley & Sons, Ltd. 其他題名： Statist. Med 出版者： England: Blackwell Publishing Ltd 出版日期： 2014-02-28 出處： Statistics in medicine, 2014-02, Vol.33 (5), p.786-797 資源來源： Wiley Online Library - AutoHoldings Journals 版權： Copyright © 2013 John Wiley & Sons, Ltd. 版權： Copyright Wiley Subscription Services, Inc. Feb 28, 2014 識別號： ISSN: 0277-6715 識別號： ISSN: 1097-0258 識別號： EISSN: 1097-0258 識別號： DOI: 10.1002/sim.5978 識別號： PMID: 24105871 識別號： CODEN: SMEDDA
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