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Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic Modeling

Award Number: U01FD007957
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic Modeling - DEVELOPMENT AND VALIDATION OF A MULTI-FUNCTIONAL, MULTI-PURPOSE QUANTITATIVE TOOL FOR DERMAL PHYSIOLOGICALLY-BASED PHARMACOKINETIC (PBPK) MODELING Project Summary Topical drug products applied to skin undergo substantial metamorphosis as they are rubbed into the application site: volatile excipients like water or alcohols evaporate, and drug and excipients absorb into the skin. The result is a residual film on the skin surface that has quite different composition and properties to the starting formulation that “came out of the tube”. Because the residence time of the residual film is typically much longer than the period during which metamorphosis occurs, drug delivery into the skin will be controlled both by the complex physical chemistry of the metamorphosis (i.e., the kinetics and thermodynamics) and by the nature of the residual film. In addition, excipients and solvents may alter drug partitioning into and diffusivity in the skin and therefore impact directly on percutaneous permeation. The objective of this work is to expand the capabilities of an existing physiologically based pharmacokinetic (PBPK) model simulating drug absorption and disposition in the skin to include metamorphosis of the drug product during and following skin application together with measurements of key formulation characteristics (quality attributes). The project will utilize experimental data, both new and from the literature, to test the hypothesis that a PBPK model that accounts correctly for metamorphosis kinetics, for relevant quality attributes of the starting product and residual film, and for the impact of excipients and co-solvents on skin absorption, will correctly predict dermal absorption and will support the bioequivalence assessment of generic topical drug products. A systematic series of increasingly complex drug products will be characterized in terms of quality attributes that have a significant impact on drug absorption by affecting (a) the kinetics and mechanism of metamorphosis, (b) drug thermodynamic activity as the product evolves to form the residual film, and (c) skin absorption of formulation excipients and co-solvents that change drug partitioning and diffusivity in the skin. A new generation of dermal PBPK models will be developed with expanded, mechanistically based capabilities accounting for product metamorphosis and the impact of quality attributes on drug delivery. These models will be validated by comparisons with in vitro and/or in vivo skin permeation measurements of topical drug products collected as part of this project and from the literature. The resulting enhanced PBPK models will be useful tools for assessing the likelihood that different dermatological drug products are or are not bioequivalent based on minimal clinical data, thereby reducing the time and cost to approve new drug products applied to skin.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF BATH	CLAVERTON DOWN	BATH				GBR	Food and Drug Administration Research	000	3	1/15/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $246,357 )
2025	2025	UNIVERSITY OF BATH	CLAVERTON DOWN	BATH				GBR	Food and Drug Administration Research	000	3	8/27/2025	NON-COMPETING CONTINUATION	$246,357
														Subtotal = $246,357

Issue Date FY: 2024 ( Subtotal = $243,950 )
2024	2024	UNIVERSITY OF BATH	CLAVERTON DOWN	BATH				GBR	Food and Drug Administration Research	000	2	8/28/2024	NON-COMPETING CONTINUATION	$243,950
														Subtotal = $243,950

Issue Date FY: 2023 ( Subtotal = $242,154 )
2023	2023	UNIVERSITY OF BATH	CLAVERTON DOWN	BATH				GBR	Food and Drug Administration Research	000	1	9/12/2023	NEW	$242,154
2023	2023	UNIVERSITY OF BATH	CLAVERTON DOWN	BATH				GBR	Food and Drug Administration Research	002	1	9/27/2023	NEW	-$242,154
2023	2023	UNIVERSITY OF BATH	CLAVERTON DOWN	BATH				GBR	Food and Drug Administration Research	001	1	9/23/2023	NEW	$0
2023	2023	UNIVERSITY OF BATH	CLAVERTON DOWN	BATH				GBR	Food and Drug Administration Research	003	1	9/28/2023	NEW	$242,154
														Subtotal = $242,154

Grand Total All Awards = $732,461

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Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic Modeling

Award Number: U01FD007957

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/05/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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