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Developing PBPK-model based mechanistic IVIVC for PLGA implants

Award Number: U01FD008303
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Developing PBPK-model based mechanistic IVIVC for PLGA implants - There is an immediate need to understand the critical formulation parameters that may affect product performance in vitro and in vivo, with a goal of developing IVIVCs for long-acting injectables. In this proposal, we will develop IVIVCs for a long-acting PLGA-based solid implant using a physiologically based pharmacokinetic (PBPK) modeling approach. PBPK modeling “provides a unique opportunity to understand how the physicochemical properties of drug molecules/polymer, implant specific properties, critical formulation attributes, and physiology, among other things, influence the in vivo release mechanisms of LAI drug products and their disposition characteristics. Successful execution of the project will entail (1) developing a bio-predictive in-vitro release testing method and determining how critical formulation and physicochemical properties impact the in-vitro release of PLGA-based buprenorphine implants; and (2) using a bottom-up PBPK approach to build IVIVCs that predict in-vivo PK profiles of PLGA-based buprenorphine implants from in-vitro data.


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 TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	000	2	11/4/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $249,645 )
2025	2025	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	001	2	8/27/2025	NON-COMPETING CONTINUATION	$249,645
2025	2024	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	000	1	12/10/2024	NEW	$0
														Subtotal = $249,645

Issue Date FY: 2024 ( Subtotal = $299,364 )
2024	2024	UNIVERSITY OF TEXAS AT AUSTIN	110 INNER CAMPUS DR	AUSTIN	TX	78712	TRAVIS	USA	Food and Drug Administration Research	000	1	9/2/2024	NEW	$299,364
														Subtotal = $299,364

Grand Total All Awards = $549,009

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Developing PBPK-model based mechanistic IVIVC for PLGA implants

Award Number: U01FD008303

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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