第10章 群体药代动力学模型模拟

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模型模拟

模型模拟简介

原理

根据参数，在不直接进行数学求解的情况下，预测药物的暴露和效应。

模拟计划

  • 模拟过程需要注意的内容：
  1. 模拟患者特征是否与真实患者典型特征匹配
  2. 模拟场景可行性
  3. 研究设计的合理性
  4. 药动学和药效学指标合理性
  5. 基于目的，模型可以为包含个体变异群体模型，也可为不包含个体变异的群体模型

模拟

包括：协变量分布模型 ，输入输出模型，试验执行模型

一、协变量分布模型

考虑受试者特征：年龄、体重、病理、遗传、合并用药等
1. 抽样
从建模数据库或者公共数据库中抽取协变量分布特征。

2. 重采样

从原始数据库中抽取

二、输入输出模型

指药动学-药效学模型，和疾病进展模型。
与模型控制文件区别：

$SIMULATION (123456) ONLYSIM SUBPROBLEM=500

$SIMULATION (123456) 定义种子数

ONLYSIM 只进行模拟不进行参数计算

SUBPROBLEM=500 模拟次数

1. 改变模型参数

改变$THETA 、 $OMEGA 、 $SIGMA 的值

2. 改变协变量

加入协变量如：

  CL = THETA(2)*(WT/70)**0.75*EXP(ETA(2))

3. 改变给药剂量等

改变数据文件AMT、EVID、TIME等

三、试验执行模型

考虑受试者的依从性，如受试者脱落，退出，偏离等

如受试者为按照计划服药，漏服等

四、数据分析与解读

通常用图法表达
90

五、注意事项

  1. 种子数
    不同模拟场景，相同种子下同一个受试者的个体变异一致

  2. 随机效应和因变量的限制
    避免得到负值：CALL SIMEPS(EPS)

正文完
NONMEM POPPK
发表至： NONMEM
2023-03-10
 
评论（37 条评论）
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