Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
CPT Pharmacometrics Syst Pharmacol. 2014 Jun 4;3(6):e117. doi: 10.1038/psp.2014.15.
Exposure-response modeling facilitates effective dosing regimen selection in clinical drug development, where the end points are often disease scores and not physiological variables. Appropriate models need to be consistent with pharmacology and identifiable from the time courses of available data. This article describes a general framework of applying mechanism-based models to various types of clinical end points. Placebo and drug model parameterization, interpretation, and assessment are discussed with a focus on the indirect response models.
暴露-反应建模有助于在临床药物开发中选择有效的给药方案，其中终点通常是疾病评分，而不是生理变量。适当的模型需要与药理学一致，并能够从现有数据的时间过程中识别出来。本文描述了一种将基于机制的模型应用于各种类型的临床终点的通用框架。讨论了安慰剂和药物模型的参数化、解释和评估，重点是间接反应模型。
