Pharmetheus AB, Uppsala, Sweden.
CPT Pharmacometrics Syst Pharmacol. 2024 May;13(5):743-758. doi: 10.1002/psp4.13116. Epub 2024 Feb 28.
The inclusion of covariates in pharmacometric models is important due to their ability to explain variability in drug exposure and response. Clear communication of the impact of covariates is needed to support informed decision making in clinical practice and in drug development. However, effectively conveying these effects to key stakeholders and decision makers can be challenging. Forest plots have been proposed to meet these communication needs. However, forest plots for the illustration of covariate effects in pharmacometrics are complex combinations of model predictions, uncertainty estimates, tabulated results, and reference lines and intervals. The purpose of this tutorial is to outline the aspects that influence the interpretation of forest plots, recommend best practices, and offer specific guidance for a clear and transparent communication of covariate effects.
由于协变量能够解释药物暴露和反应的变异性,因此在药代动力学模型中纳入协变量非常重要。需要清楚地沟通协变量的影响,以支持临床实践和药物开发中的明智决策。然而,有效地将这些效果传达给关键利益相关者和决策者可能具有挑战性。森林图被提议来满足这些沟通需求。然而,用于说明药代动力学中协变量影响的森林图是模型预测、不确定性估计、表格结果以及参考线和区间的复杂组合。本教程的目的是概述影响森林图解释的各个方面,推荐最佳实践,并为协变量影响的清晰透明沟通提供具体指导。