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

Clin Pharmacol Ther. 2020 Apr;107(4):934-943. doi: 10.1002/cpt.1787. Epub 2020 Feb 11.


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Analgesics, Opioid / pharmacokinetics
  • Data Interpretation, Statistical*
  • Databases, Factual / statistics & numerical data
  • Electronic Health Records / statistics & numerical data*
  • Female
  • Fentanyl / pharmacokinetics*
  • Humans
  • Lamotrigine / pharmacokinetics*
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing / methods
  • Product Surveillance, Postmarketing / statistics & numerical data*
  • Tacrolimus / pharmacokinetics*
  • Young Adult


  • Analgesics, Opioid
  • Lamotrigine
  • Fentanyl
  • Tacrolimus