# Natural Product-Drug Interaction Research: The Roadmap to Best Practices

> **NIH NIH U54** · WASHINGTON STATE UNIVERSITY · 2024 · $2,094,143

## Abstract

PROJECT SUMMARY OF THE OVERALL U54 CENTER
Assessing the risk of adverse natural product (NP)-drug interactions (NPDIs) is of paramount importance due to
the exponential NP sales growth in the US. This effort is challenged by relatively scant pharmacokinetic
knowledge of individual NP constituents that precipitate these interactions and a lack of mechanistic
understanding of NP effects on drug disposition. Investigations of NPDIs to address these knowledge gaps are
complicated by the inherently large variability in phytoconstituent composition of supposedly the same NP,
acquisition of sufficient high-quality NP study materials, and the diverse populations to which NPs are marketed,
including the elderly. Our established Center of Excellence for Natural Product Drug Interaction Research
(NaPDI Center) was created by the National Center for Complementary and Integrative Heath (NCCIH) in 2015
to address this public health problem. A cross-disciplinary research team composed of experts in clinical
pharmacology, NP chemistry, biomedical informatics, and health communications led the charge to address the
challenges unique to NPDI research. As detailed in this renewal application, we will advance the mission of the
NaPDI Center by designing and executing new mechanistically-driven Interaction Projects, expanding the utility
of our web-based data repository and public portal, and broadening dissemination of knowledge to national and
international research communities. These activities will be accomplished through synergistic interactions
between three established scientific Cores (Pharmacology, Analytical, and Informatics) and an overarching
Administrative Core. The Pharmacology Core will expand an innovative method to select three to five high priority
NPs to study as precipitants of potential clinically significant NPDIs. The Analytical Core will source and fully
characterize the chemical composition of commercially available, representative NPs and provide NP study
materials free of adulterants and contaminants for the Interaction Projects. The Pharmacology Core will design
and execute rigorous in vitro studies to establish the mechanism of NP effects on drug disposition; predict the
magnitude of NPDIs using physiologically-based pharmacokinetic modeling and simulation; and design and
conduct clinical NPDI studies. The Analytical Core will provide quantitative analysis of object drugs, NP
constituents, and emerging drug disposition biomarkers in the human pharmacokinetic samples. The interpreted
data generated from the Interaction Projects will be transferred to the data repository developed and maintained
by the Informatics Core. Major findings will be disseminated to scientific and other interested communities
through our unique public access web portal perpetuated by the Informatics Core. All Cores will share the task
of broadening Center outreach activities through targeted workshops and symposia at national and international
scientific meetings. ...

## Key facts

- **NIH application ID:** 10909101
- **Project number:** 5U54AT008909-10
- **Recipient organization:** WASHINGTON STATE UNIVERSITY
- **Principal Investigator:** MARY F PAINE
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $2,094,143
- **Award type:** 5
- **Project period:** 2015-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10909101

## Citation

> US National Institutes of Health, RePORTER application 10909101, Natural Product-Drug Interaction Research: The Roadmap to Best Practices (5U54AT008909-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10909101. Licensed CC0.

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