基于模型的meta分析在药物研发中的应用

Model Based Meta-analysis in Drug Development

基于模型的meta分析(MBMA)是近年来新提出的一种用于药物研发的定量分析方法,通过建立药效学模型和统计模型,合并临床研究,并引入协变量来考察药物剂量、疗程、基线等因素对疗效的影响,且基于药效学模型进行不同给药方式或不同严重程度下药效的模拟和预测。MBMA是药物研发过程中比较药物疗效、制定药物研发决策以及优化给药方案的一个重要工具。简述MBMA方法及其特点,重点介绍近年来国内外有关MBMA在药物研发中应用情况,以期为MBMA在药物研发过程中进一步研究与应用提供参考。

Model based meta-analysis （MBMA） is a new type of quantitative analysis method in drug development. It provides statistical models and pharmacodynamics models for integration of clinical trials, investigates the impact of dosage, treatment duration and morbid states on treatment effect by introducing covariates and simulate and predict drug efficacy of different routes of administration and seriousness of disease with pharuaacodynamics models. MBMA is an important quantitative tool in drug development for comparing drug efficacy, formulating drug development strategies and optimizing drug regimen. This paper overviewed the methods and characteristics of MBMA, as well as worldwide applications of MBMA in drug development in recent years, so as to provide reference for further study and application of MBMA in drug development.