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Development and validation of dermal PBPK modelling platform towards virtual bioequivalence assessment considering population variability

Award Number: U01FD005225
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract Occasional disparity between the animal and human data plus rising public interest and regulatory requirements to reduce animal usage in research combined with high cost and time- consuming attributes of animal experiments have fuelled the development of economically viable and scientifically reliable in silico and in vitro methods to assess dermal drug absorption. Among other modelling approaches physiologically based pharmacokinetic (PBPK) models have a unique advantage in that they consider separately the drug and the formulation characteristics from the underlying physiology and its variability. Hence, they are better positioned to predict the kinetics for a population including inter-individual variability allowing them to be a powerful product performance assessment tool from an industrial and regulatory perspective. The other perceived advantage of PBPK approach is the possibility of extrapolations. Once the model is validated for a particular drug/formulation in one population e.g. healthy volunteer, it can be assessed with confidence for another population e.g. elderly provided the demographical, anatomical, and physiological differences between healthy and elderly populations are well characterised. Simcyp® Population-Based ADME Simulator offers flexible and scientifically validated algorithms for various PBPK models including dermal absorption module. The simulator platform has been developed with a main focus on clinical trials simulation incorporating the inter-individual variability during simulations rather than just the ‘average person’ and is being used by most of the big pharmaceutical companies and regulatory agencies across the world. We aim to incorporate new mechanisms that play important roles in dermal absorption, namely, skin surface pH, dermal hydration, skin appendages, bonding to keratin, effect of permeability-modifying formulation ingredients and drug-physiology interactions. The physiology data such as thickness, lipid content pH, hydration level, microvasculature and density of hair follicles in skin from various parts of body for healthy volunteer, paediatric, geriatric and other special populations will be collected, verified, analysed and incorporated into the platform. Additionally a deep tissue compartment will be provided to simulate drug permeation into subcutaneous tissue for locally acting drugs at the site of action and link it to the pharmacodynamics model to simulate the drug effect. The performance verification of the developed model and physiology will be carried out and disseminated to the general scientific community through appropriate channels.


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: 2021 ( Subtotal = $0 )
2021	2016	CERTARA UK LIMITED	LEVEL 2-ACERO, 1 CONCOURSE WAY,	SHEFFIELD	SOUTH YORKSHIRE			GBR	Food and Drug Administration Research	000	3	3/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	SIMCYP LTD	BLADES ENTERPRISE CENTRE	SHEFFIELD	SOUTH YORKSHIRE	S2 4SU		GBR	Food and Drug Administration Research	000	3	1/31/2017	NON-COMPETING CONTINUATION	$0
2017	2016	SIMCYP LTD	BLADES ENTERPRISE CENTRE	SHEFFIELD	SOUTH YORKSHIRE	S2 4SU		GBR	Food and Drug Administration Research	001	3	7/28/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $134,950 )
2016	2016	Simcyp Ltd	Blades Enterprise Centre	Sheffield				GBR	Food and Drug Administration Research	000	3	8/25/2016	NON-COMPETING CONTINUATION	$134,950
														Subtotal = $134,950

Issue Date FY: 2015 ( Subtotal = $130,445 )
2015	2015	Simcyp Ltd	Blades Enterprise Centre	Sheffield				GBR	Food and Drug Administration Research	001	2	8/24/2015	NON-COMPETING CONTINUATION	$130,445
2015	2014	Simcyp Ltd	Blades Enterprise Centre	SHEFFIELD		S2 4S		GBR	Food and Drug Administration Research	000	1	12/11/2014	NEW	$0
														Subtotal = $130,445

Issue Date FY: 2014 ( Subtotal = $126,114 )
2014	2014	Simcyp Ltd	Blades Enterprise Centre	Sheffield				GBR	Food and Drug Administration Research	000	1	9/10/2014	NEW	$126,114
														Subtotal = $126,114

Grand Total All Awards = $391,509

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Development and validation of dermal PBPK modelling platform towards virtual bioequivalence assessment considering population variability

Award Number: U01FD005225

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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