摘要
目的介绍一种估算临床试验初始剂量的药动-药效学结合方法。方法该法包括四个基本步骤:确定药物对动物的暴露-剂量关系;预测人的暴露-剂量关系;预测人的ADME特征与药动学参数;预测人的剂量-效应关系并估算临床初始剂量。结果以一种药物为例,以该法计算起始剂量与FDA推荐最大安全剂量法估算剂量相近。结论该法可用于临床起始剂量估算。
Aim To introduce a new pharmacodynamic and pharmacokinetic intergrated approach that determines starting dose for firstin-human trials.Methods The four basic steps were characterization exposure-response relationships observed in animal experiments,correction for interspecies difference and prediction of human exposure-response relationships,diagnosing and predicting pharmacokinetic properties of the drug in human,prediction of human dose-responses and dose selection for first-in-human trials.Results The approach predicted that the dose for a drug was similar to MRSD approach recommended by FDA.Conclusion The new approach can be used to determine starting dose for first-in-human trials.
出处
《安徽医药》
CAS
2012年第1期117-119,共3页
Anhui Medical and Pharmaceutical Journal
关键词
首次临床实验
初始剂量
药动-药效学结合方法
first-in-human trials
starting dose
pharmacokinetics and pharmacodynamics approach
