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Dan Roden
Faculty Member
Last active: 3/24/2020

Development of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real-World Data From Electronic Health Records.

Choi L, Beck C, McNeer E, Weeks HL, Williams ML, James NT, Niu X, Abou-Khalil BW, Birdwell KA, Roden DM, Stein CM, Bejan CA, Denny JC, Van Driest SL
Clin Pharmacol Ther. 2020 107 (4): 934-943

PMID: 31957870 · PMCID: PMC7093250 · DOI:10.1002/cpt.1787

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.

© 2020 The Authors Clinical Pharmacology & Therapeutics © 2020 American Society for Clinical Pharmacology and Therapeutics.

MeSH Terms (16)

Adolescent Adult Aged Analgesics, Opioid Databases, Factual Data Interpretation, Statistical Electronic Health Records Female Fentanyl Humans Lamotrigine Male Middle Aged Product Surveillance, Postmarketing Tacrolimus Young Adult

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