# System construction for population pharmacokinetic and pharmacodynamic modeling using electronic health records: toward precision medicine

> **NIH NIH R01** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2021 · $308,037

## Abstract

Project Summary
 
In order to improve patient outcomes, factors that can reduce variability in treatment must be identified
and quantified. For drug therapies, individual differences in pharmacokinetics (PK) and
pharmacodynamics (PD) are major sources of variability. Population PK/PD studies have been proven to
be very useful to identify these factors, but are underutilized. A major barrier to this approach is the
difficulty of obtaining data from a large number of patients, which requires precise time information and
accurate values for dosing and drug plasma concentration or response measurements appropriately
formatted for PK/PD studies. Electronic health records (EHRs) are potentially an excellent source for
such data, but standardized methods for data extraction and preprocessing for PK/PD modeling are
lacking. We will work to develop methods for abstraction, validation and preprocessing of EHR data to
construct data for PK/PD studies. In Aim 1, we will develop programs for data preprocessing and building
PK/PD datasets, and validate the developed programs using the test datasets. In Aim 2, we will evaluate
the robustness of data construction system using EHRs by performing tipping point analyses by
intentionally introducing errors into test datasets. This approach is highly recommended by the Food and
Drug Administration to determine the sensitivity of analysis to methods of handling missing data. In Aim 3,
we will develop a preliminary dose optimization algorithm for tacrolimus based on a Bayesian PK/PD
prediction model, which will serve as a basis for a clinical support decision tool for future study. A more
efficient and standardized system for data construction will promote population based PK/PD studies by
providing a PK/PD data pipeline. The ultimate product of this work will be a generalizable and validated
data pipeline for analysis of drug exposures and responses using EHR data, which will be widely
applicable to many population studies for an array of medications. Our validated system will extend
opportunities to a wider research community to perform population based PK/PD studies and facilitate
the chance of finding factors affecting PK/PD profiles. This research will be utilized to advance precision
medicine across a wide array of therapies.

## Key facts

- **NIH application ID:** 10133675
- **Project number:** 5R01GM124109-05
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Leena Choi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $308,037
- **Award type:** 5
- **Project period:** 2017-07-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10133675

## Citation

> US National Institutes of Health, RePORTER application 10133675, System construction for population pharmacokinetic and pharmacodynamic modeling using electronic health records: toward precision medicine (5R01GM124109-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10133675. Licensed CC0.

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