基于GastroPlus™软件的阿托伐他汀片生物等效性的计算机预测

IF 2.8 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Lu Wang, Jinliang Chen, Wenjun Chen, Zourong Ruan, Honggang Lou, Dandan Yang, Bo Jiang
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引用次数: 0

摘要

基于计算机模拟的各种药物的肠道吸收预测已经成为现实。然而,基于GastroPlus™的体内药代动力学模拟和虚拟生物等效性评估尚未发现。本研究旨在模拟不同溶出度的血浆浓度,并使用GastroPlus软件进行人群模拟,以评估阿托伐他汀的试验产品和参比产品的生物等效性。采用阿托伐他汀(20mg片剂)对照品和试验品的溶出度曲线,以及对照品的临床血药浓度-时间数据进行模拟。结果表明,所建立的阿托伐他汀片的模拟模型是成功的。种群模拟结果表明,试验制剂与参比制剂具有生物等效性。研究结果表明,建模是证明阿托伐他汀的药代动力学和生物等效性的可能性的重要工具。这将有助于了解仿制药开发过程中的潜在风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
In silico prediction of bioequivalence of atorvastatin tablets based on GastroPlus™ software.

The prediction of intestinal absorption of various drugs based on computer simulations has been a reality. However, in vivo pharmacokinetic simulations and virtual bioequivalence evaluation based on GastroPlus™ have not been found. This study aimed to simulate plasma concentrations with different dissolution profiles and run population simulations to evaluate the bioequivalence of test and reference products of atorvastation using GastroPlus software. The dissolution profiles of the reference and test products of atorvastatin (20 mg tablets), and clinical plasma concentration-time data of the reference product were used for the simulations. The results showed that the simulated models were successfully established for atorvastatin tablets. Population simulation results indicated that the test formulation was bioequivalent to the reference formulation. The findings suggest that modelling is an essential tool to demonstrating the possibility of pharmacokinetic and bioequivalence for atorvastatin. It will contribute to understanding the potential risks during the development of generic products.

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来源期刊
BMC Pharmacology & Toxicology
BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY
CiteScore
4.80
自引率
0.00%
发文量
87
审稿时长
12 weeks
期刊介绍: BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.
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