Development of a System for Post-marketing Population Pharmacokinetic and Pharmacodynamic Studies using Real-World Data from Electronic Health Records.
Clicks: 306
ID: 85143
2020
Post-marketing 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 post-marketing population PK/PD studies using information available in EHRs.
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| Authors | Choi, Leena;Beck, Cole;McNeer, Elizabeth;Weeks, Hannah L;Williams, Michael L;James, Nathan T;Niu, Xinnan;Abou-Khalil, Bassel W;Birdwell, Kelly A;Roden, Dan M;Stein, C Michael;Bejan, Cosmin A;Denny, Joshua C;Van Driest, Sara L; |
| Journal | clinical pharmacology and therapeutics |
| Year | 2020 |
| DOI | 10.1002/cpt.1787 |
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