论文检索

以剂量为工具变量、利用暴露数据稳健估计因果剂量响应关系AI 解读

An accurate estimation of the dose-response relationship is important to determine the optimal dose. For this purpose, a dose finding trial in which subjects are randomized to a few fixed dose levels is the most commonly used design. Often, the estimation uses response data only, although drug exposure data are often obtained during the trial. The use of exposure data to improve this estimation is difficult, as exposure-response relationships are typically subject to…

剂量—暴露—响应建模对剂量响应估计与优化的收益AI 解读

In randomized dose-finding trials, although drug exposure data form a part of key information for dose selection, the evaluation of the dose-response (DR) relationship often mainly uses DR data. We examine the benefit of dose-exposure-response (DER) modeling by sequentially modeling the dose-exposure (DE) and exposure-response (ER) relationships in parameter estimation and prediction, compared with direct DR modeling without PK data. We consider ER modeling approaches with…