Postmarketing population pharmacokinetic (PK) and pharmacodynamic (PD) studies can be useful to capture patient characteristics affecting PK or PD in real-world settings. These studies require longitudinally measured dose, outcomes, and covariates in large numbers of patients; however, prospective data collection is cost-prohibitive. Electronic health records (EHRs) can be an excellent source for such data, but there are challenges, including accurate ascertainment of drug dose. We developed a standardized system to prepare datasets from EHRs for population PK/PD studies. Our system handles a variety of tasks involving data extraction from clinical text using a natural language processing algorithm, data processing, and data building. Applying this system, we performed a fentanyl population PK analysis, resulting in comparable parameter estimates to a prior study. This new system makes the EHR data extraction and preparation process more efficient and accurate and provides a powerful tool to facilitate postmarketing population PK/PD studies using information available in EHRs.

中文翻译：

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使用来自电子健康记录的真实数据开发上市后人群药代动力学和药效学研究系统。

上市后人群药代动力学 (PK) 和药效学 (PD) 研究可用于捕捉在现实环境中影响 PK 或 PD 的患者特征。这些研究需要对大量患者进行纵向测量的剂量、结果和协变量；然而，前瞻性数据收集成本高昂。电子健康记录 (EHR) 可以成为此类数据的极好来源，但也存在挑战，包括准确确定药物剂量。我们开发了一个标准化系统来准备来自 EHR 的数据集，用于人群 PK/PD 研究。我们的系统处理涉及使用自然语言处理算法、数据处理和数据构建从临床文本中提取数据的各种任务。应用该系统，我们进行了芬太尼群体 PK 分析，导致与先前研究的可比参数估计。这个新系统使 EHR 数据提取和准备过程更加高效和准确，并提供了一个强大的工具，以促进使用 EHR 中可用的信息进行上市后人群 PK/PD 研究。