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Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems

Award Number: U01FD006522
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems - Project summary. This project will address the need to incorporate formulation drug product quality attributes in dermal physiologically-based pharmacokinetic (PBPK) models for topical dermatological drug products and transdermal delivery systems (RFA-FD-18-019). This will be achieved by a collaborative partnership involving academia, industry and the FDA. We will begin the project using the MechDermA PBPK model, developed by the industry partner, Simcyp, as our core PBPK model. We will collect pertinent literature and undertake appropriate in house studies to define necessary drug product quality attributes from a wide range of formulations to be included in the model. At the same time, we will explore the further development of the model to account for active pharmaceutical ingredient (API) – product – skin interactions during the metamorphosis of various products applied to human skin. We will also compare outputs from the MechDermA PBPK model with those obtained from the Roberts team and literature models, especially geometrically complex 3D microstructure diffusion based models. We will also consider the impact of corneocyte wall permeability, binding, SC heterogeneity and dermal blood/lymphatic flow on the dermal absorption for a range of APIs with different physicochemical properties on skin permeation using literature, in silico and in house experimental data. In addition, we will examine the impact of variability in application at a given application site and between individuals in a larger population. These findings will then be used to further develop the MechDermA PBPK model to improve its flexibility, sensitivity and overall predictability. This analysis will then be used to classify APIs for dermal absorption for various products in a scheme like the Biopharmaceutics Drug Classification approach used for oral products. We will also validate/qualify the further developed MechDermA PBPK model using in vivo data sets obtained from the literature, complemented as needed by in vitro skin permeation test (IVPT) studies. Lastly, we will use the model to simulate virtual bioequivalence studies and to evaluate bioequivalence for generic drug formulations. This work will include collecting bioequivalence data for different API types, undertaking a global sensitivity analyses, performing virtual bioequivalence studies in healthy volunteers, and special populations such as elderly or pediatric populations and verifying model performance for various clinical scenarios.


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: 2022 ( Subtotal = $0 )
2022	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE				AUS	Food and Drug Administration Research	000	2	1/10/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	001	2	8/13/2020	NON-COMPETING CONTINUATION	$0
2020	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	000	2	1/10/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $250,000 )
2019	2019	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	001	2	7/19/2019	NON-COMPETING CONTINUATION	$250,000
2019	2018	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	000	1	2/8/2019	NEW	$0
														Subtotal = $250,000

Issue Date FY: 2018 ( Subtotal = $250,000 )
2018	2018	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	001	1	8/29/2018	NEW	$0
2018	2018	THE UNIVERSITY OF QUEENSLAND	UNIVERSITY OF QUEENSLAND	BRISBANE		4072		AUS	Food and Drug Administration Research	000	1	8/28/2018	NEW	$250,000
														Subtotal = $250,000

Grand Total All Awards = $500,000

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Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems

Award Number: U01FD006522

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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