# Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with Obesity

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2022 · $214,861

## Abstract

ABSTRACT
Children with obesity are often prescribed drugs without adequate dosing information to account for size and
age. Dose adjustments in obese children may be required due to physiologic and body composition changes, as
well as alterations in the function of drug eliminating organs, both of which can affect drug disposition.
Physiologically-based pharmacokinetic (PBPK) models are mathematical constructs that incorporate physiologic
and body composition changes during childhood. By incorporating physiologic and body composition changes
with information about the drug's physicochemical properties, PBPK models can be used to predict drug
disposition and optimize drug dosing in children with obesity. This proposal will use a systematic approach to
developing and evaluating PBPK models in children with obesity, which will provide informed drug dosing in this
vulnerable population. We have selected 12 drugs prescribed to children with obesity across the 4
Biopharmaceutical Drug Disposition Classification System (BDDCS) classes, which will allow us to characterize
the effect of obesity for drugs that exhibit varying physicochemical and metabolic properties. For these 12 drugs,
available pharmacokinetic (PK) data collected from children with obesity will be used to develop PBPK models
that incorporate known obesity-induced physiological changes. Then we will develop PBPK models to predict
the effect of obesity for 4 additional drugs (one per BDDCS class), and prospectively collect drug concentration
data to evaluate these models. The developed models will be used to guide dosing in children with obesity. Once
established, this approach will be applied to other commonly used drugs, which will inform dosing of all drugs
used in children with obesity or 12.7 million children and adolescents in the U.S.

## Key facts

- **NIH application ID:** 10456301
- **Project number:** 5R01HD096435-05
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Julie Brumer Dumond
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $214,861
- **Award type:** 5
- **Project period:** 2018-09-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10456301

## Citation

> US National Institutes of Health, RePORTER application 10456301, Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with Obesity (5R01HD096435-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10456301. Licensed CC0.

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