# Pharmacometrics and Clinical Trial Design Core

> **NIH NIH P30** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $832,822

## Abstract

Summary (Pharmacometrics and Clinical Trial Design Core)
The Pharmacometrics and Clinical Trial Design (PCTD) Core of the Indiana University-Ohio State University
Maternal and Pediatric Precision in Therapeutics Data, Model, Knowledge, and Research Coordination Center
(IU-OSU MPRINT DMKRCC) will provide expertise in pharmacometrics and clinical trial design relating to
maternal and pediatric therapeutics. The PCTD will also integrate data from the Knowledgebase and Portal Core,
Real World Evidence Core, and other collaborators to support development of pharmacometric models in
pregnant and lactating women and children to provide mechanistic insight into changes in drug disposition and
response across the lifespan and sources of inter- and intra-individual variability. The Aims of the PCTD will 1)
bring together pharmacometricians and clinical pharmacologists with expertise in obstetrics and pediatrics to
contribute to guidelines for data quality, utilize cutting-edge pharmacometric and data science methods (in
conjunction with Knowledgebase Core), and assist in developing and analyzing data from obstetric-pediatric
clinical pharmacology research; 2) Facilitate utilization of data and identification of gaps in knowledge from in
vitro, preclinical, and clinical studies by incorporating this information into integrative physiologically based
pharmacokinetic-pharmacodynamic (PBPK-PD) models that encompass dynamic changes in maternal
physiology across gestation and postpartum, including lactation models, link to neonates, and describe
maturation throughout childhood. PBPK-PD models will incorporate critical sources of inter- and intra-individual
variability, including but not limited to pharmacogenomics, obesity, concomitant disease, and disability, to provide
a platform to inform precision therapy in maternal and child health; and 3) Serve as a national and international
resource by enhancing model informed drug development, clinical study design and personalized
pharmacotherapy at various stages of pregnancy and pediatric development through implementation of novel
pharmacometric modeling approaches. The PCTD will work with the MPRINT Hub Steering Committee to set
research priorities and milestones and with the Outreach, Dissemination and Training Core to disseminate
results and provide education on pharmacometric approaches applied to maternal and pediatric therapeutic
research.

## Key facts

- **NIH application ID:** 10487579
- **Project number:** 5P30HD106451-02
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Sara K Quinney
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $832,822
- **Award type:** 5
- **Project period:** 2021-09-10 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10487579

## Citation

> US National Institutes of Health, RePORTER application 10487579, Pharmacometrics and Clinical Trial Design Core (5P30HD106451-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10487579. Licensed CC0.

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