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CONSAM在复杂给药方案的模拟、分析和优化方面的简便实用。

Easy and practical utilization of CONSAM for simulation, analysis, and optimization of complex dosing regimens.

作者信息

Jackson A J, Zech L A

机构信息

Division of Bioequivalence, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857.

出版信息

J Pharm Sci. 1991 Apr;80(4):317-20. doi: 10.1002/jps.2600800406.

Abstract

Complex dosing regimens simulated in the literature using a universal dosing regimen were calculated with a general dosing program developed using the program CONSAM. The program provides a rapid method of calculating nonuniform dosing regimens for up to n = 3 compartments for any linear model. Subject data can also be curve fitted with the program to obtain individual subject estimates to allow for dosage optimization, which is important in a clinical setting. Examples are presented to show the use of the program in optimizing a theophylline regimen, as well as estimation of a new parameter, Cuneq(T), which is defined as the average non-steady-state drug concentration at time t for a drug with an irregular dosing interval.

摘要

文献中使用通用给药方案模拟的复杂给药方案,是通过使用CONSAM程序开发的通用给药程序计算得出的。该程序提供了一种快速方法,可针对任何线性模型计算多达n = 3个房室的非均匀给药方案。还可以使用该程序对受试者数据进行曲线拟合,以获得个体受试者估计值,从而实现剂量优化,这在临床环境中很重要。文中给出了示例,展示了该程序在优化茶碱给药方案中的应用,以及一个新参数Cuneq(T)的估计,该参数定义为给药间隔不规则的药物在时间t时的平均非稳态药物浓度。

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