置信区间法用于线性药代动力学特征评价

Using confidence interval method to assess linear pharmacokinetics in dose escalation study

目前有多种评价线性药代动力学的方法,需要对线性动力学特征评价方法标准化、规范化。置信区间法综合考虑统计学知识与临床实践经验,将变异纳入考察范围,更符合药代动力学研究的要求。本文推荐用置信区间法评价药物线性动力学特征,有助于今后线性评价的标准化。

There are many clinically relevant approaches to linear pharmacokinetic analyses,which need to be normalized. Confidence interval criteria considering statistics,clinical experience and the variance,is more in line with the requirements of pharmacokinetic study. In this paper,we recommend using confidence interval method for the evaluation of linear pharmacokinetics.