基于体外模型数据模拟和预测人体内群体药代参数

中国临床药理学与治疗学 ›› 2008, Vol. 13 ›› Issue (5): 545-551.

基于体外模型数据模拟和预测人体内群体药代参数

汪音^1,2, 杨劲¹, 傅继华², 刘晓东¹, 王广基¹

¹中国药科大学药物代谢动力学重点实验室, ²生理研究室, 南京210009, 江苏

收稿日期:2007-12-21 修回日期:2008-02-26 发布日期:2020-11-09
通讯作者: 杨劲, 男, 副教授, 研究方向:药物代谢动力学和生物统计学。Tel:025-83271386 E-mail:yangjingqw @263.net;傅继华, 男, 副教授, 研究方向:生理药理学。Tel:025-85339624 E-mail:fjhn @sohu. com
作者简介:汪音, 女, 硕士研究生, 研究方向:药物代谢动力学。Tel:025-83271386 E-mail:wy520cat @163.com

Simulation and prediction of in vivo drug metabolism in human population based on in vitro-in vivo extrapolations

WANG Yin^1,2, YANG Jin¹, FU Ji-hua², LIU Xiao-dong¹, WANG Guang-ji¹

¹Key Laboratory of Drug Metabolism and Pharmacokinetics, ²Department of Physiology, China Pharmaceutical University, Nanjing 210009, Jiangsu, China

Received:2007-12-21 Revised:2008-02-26 Published:2020-11-09

摘要/Abstract

摘要： 新药的失败主要归因于其在人体内药效与安全性的缺乏。如果在临床试验前, 能够借助体内外相关性对其人体内的药动学参数进行预测, 将会大大提高新药筛选的效率。本文将就基于PBPK 模型的预测软件———Simcyp^?预测药物清除率的意义、计算原理、应用情况作一综述, 并对其使用前景进行展望。

关键词: Simcyp^®, 生理药物代谢动力学模型, 基于体外数据的体内数据预测, 清除率

Abstract: The major failure of new drug has been blamed on deficiencies in in vivo studies of drug efficacy and safety. It will improve the efficient of drug screen, if predicting in vivo pharmacokinetic parameters through in vitro-in vivo extrapolations (IVIVE), before the clinical trails. In this review, the significance, calculation, and application of in vivo drug clearance through Simcyp, a predictive software based on PBPK model, will be reviewed. Finally, some perspective of Simcyp were discussed.

Key words: Simcyp, PBPK model, in vitro-in vivo extrapolation, clearance

中图分类号:

R969

汪音, 杨劲, 傅继华, 刘晓东, 王广基. 基于体外模型数据模拟和预测人体内群体药代参数[J]. 中国临床药理学与治疗学, 2008, 13(5): 545-551.

WANG Yin, YANG Jin, FU Ji-hua, LIU Xiao-dong, WANG Guang-ji. Simulation and prediction of in vivo drug metabolism in human population based on in vitro-in vivo extrapolations[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(5): 545-551.

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