biostudies-literatureChoi LNCATS NIH HHSDoris Duke Charitable FoundationNational Institutes of HealthNIGMS NIH HHS934-943https://www.ebi.ac.uk/biostudies/studies/S-EPMC7093250biostudies-literatureUnknown107(4)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.Clinical pharmacology and therapeuticsDevelopment of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real-World Data From Electronic Health Records.PMC7093250GM131770GM124109R01 GM124109K23 GM100183GM115305P50 GM1153052017075TL1 TR002244R35 GM131770McNeer ERoden DMBejan CAWeeks HLChoi LBirdwell KAStein CMNiu XWilliams MLAbou-Khalil BWBeck CJames NTVan Driest SLDenny JCfalseDevelopment of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real-World Data From Electronic Health Records.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.2020-01-01T00:00:00Z2020 Apr2024-11-21T00:52:18.014Z2020-10-29T12:04:41ZS-EPMC70932503195787010.1002/cpt.1787