# Elucidating Fundamental Principles of Dermal Pharmacokinetics via Microdialysis

> **NIH FDA U01** · LONG ISLAND UNIVERSITY BROOKLYN CAMPUS · 2021 · $250,000

## Abstract

PROJECT SUMMARY: This project responds to Funding Opportunity RFA-FD-20-019, “Bioequivalence of
Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or
Microperfusion Techniques (U01)”. The purpose of this proposal is to elucidate how pharmacokinetic
principles and concepts (e.g., dose, fraction of drug absorbed, apparent volume of distribution, Cmax,
AUCinfinity) should be applied or adapted when evaluating the rate and extent to which a topically applied
compound becomes available in the dermis, at or near a site of action within the skin. The proposed
work uses in vivo microdialysis to characterize dermis pharmacokinetics following the administration of
drugs (i) directly in dermis via a retrodialysis/microdialysis approach (dermal infusion), and (ii) topically,
from dermatological formulations. The results of these studies will permit a thorough characterization
of dermis permeability (absorption), distribution, metabolism, and elimination (ADME), which will
elucidate whether or not the fundamental assumptions that underlie bioequivalence assessment for
systemic formulations can be applied to topical formulations. In addition, characterization of dermal
ADME processes can be used to develop new strategies, concepts, and endpoints to address the issue of
bioequivalence of topical dermatological drug products.

## Key facts

- **NIH application ID:** 10202604
- **Project number:** 5U01FD006930-02
- **Recipient organization:** LONG ISLAND UNIVERSITY BROOKLYN CAMPUS
- **Principal Investigator:** GRAZIA STAGNI
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $250,000
- **Award type:** 5
- **Project period:** 2020-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10202604

## Citation

> US National Institutes of Health, RePORTER application 10202604, Elucidating Fundamental Principles of Dermal Pharmacokinetics via Microdialysis (5U01FD006930-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10202604. Licensed CC0.

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