# PBPK and Population Modeling Seamlessly Linked to Clinical Trial Simulation in an Open-Source Software Platform

> **NIH FDA U01** · CHILDREN'S HOSPITAL OF LOS ANGELES · 2020 · $297,023

## Abstract

The goal of this project is to develop a comprehensive, open-source software platform for bioequivalence (BE)
study design. Components of the platform will implement a framework for population modeling based on physiological-
ly-based pharmacokinetic (PBPK) models integrated with a trial simulator. The framework will consist of: 1) Model
structures appropriate for a wide range of compounds and routes of administration; 2) Diverse and robust parametric
and nonparametric methods for population modeling to update prior PBPK model parameter value distributions with
individual data; 3) Simulation of a variety of BE trial designs with standard and novel optimal sampling strategies; 4)
Software implementation of an integrated workflow. To build the framework, the project will focus on the following
aims that align with the workflow. Aim 1: Add inhalational and dermal penetration routes to existing intravenous and
oral routes in the Open Systems Pharmacology (OSP) Suite and an in vitro-in vivo formulation/dissolution correlation
module. Aim 2: Integrate a variety of parametric and nonparametric population algorithms based in part upon the Pmet-
rics package for R to update PBPK models when individual data are available. Aim 3: Develop a BE trial simulator by re-
purposing existing capabilities within OSP and Pmetrics to simulate output for a wide range of BE trial designs, incorpo-
rating standard and novel optimal sampling algorithms and existing R modules for sample size calculations and analysis
of predicted trial outcomes. Aim 4: Implement a seamlessly integrated software workflow of model building, updating
and simulating, hosted on the OSP platform, and using state of the art engineering to create a freely available, open-
source product.

## Key facts

- **NIH application ID:** 9981425
- **Project number:** 5U01FD006549-03
- **Recipient organization:** CHILDREN'S HOSPITAL OF LOS ANGELES
- **Principal Investigator:** Andrea Edginton
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $297,023
- **Award type:** 5
- **Project period:** 2018-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9981425

## Citation

> US National Institutes of Health, RePORTER application 9981425, PBPK and Population Modeling Seamlessly Linked to Clinical Trial Simulation in an Open-Source Software Platform (5U01FD006549-03). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/9981425. Licensed CC0.

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