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,尚未发现基于GastroPlus™的体内药代动力学模拟和虚拟生物等效性评估。本研究旨在模拟具有不同溶解曲线的血浆浓度,并运行群体模拟,以使用GastroPlus软件评估阿托伐他汀的测试和参考产品的生物等效性。阿托伐他汀(20mg片剂)的参考和测试产品的溶出曲线,和参考产品的临床血浆浓度-时间数据用于模拟。结果表明,成功建立了阿托伐他汀片的模拟模型。群体模拟结果表明测试制剂与参考制剂生物等效。研究结果表明,建模是证明阿托伐他汀药代动力学和生物等效性可能性的重要工具。这将有助于了解仿制产品开发过程中的潜在风险。
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.