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Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM-PBPK models

Award Number: U01FD007906
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 workflow to conduct virtual bioequivalence studies using PBBM-PBPK models - Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM- PBPK models. – Project Summary This project aims to define and validate a workflow to demonstrate bioequivalence using in silico mechanistic models. The offerors decided to focus on PBBM-PBPK models and will use two separate software to perform the analysis: GastroPlus© and PK-SIM©. By doing so, advantages, limitations, and gaps will be identified across leading platforms used to describe the ADME of APIs. This goal will be achieved through three elements: (1) identification of case studies in the University of Maryland and other partners’ databases; (2) validation of the ability of GastroPlus and PK-SIM to predict the inter- and intrasubject variability; (3) simulation of informative scenario to support the establishment of the virtual bioequivalence workflow in collaboration with FDA scientist. Case studies’ datasets will support the development and validation of PBBM-PBPK models for multiple APIs on both platforms. Then, virtual populations simulation will be compared with observed individual PK concentration time courses to assess the ability of both platforms to describe the clinically observed intersubject variability. Based on the results, quantifiable validation criteria will be developed. Those will serve as a checkpoint in the workflow before conducting any virtual bioequivalence study. The PBBM-PBPK models will then be used to perform multiple virtual bioequivalence studies, and the results will be compared with either positive or negative case studies from collaborators’ datasets. Informative scenarios will be simulated to support the development of the workflow based on drug product characteristics (e.g., high variability, narrow therapeutic index). Furthermore, the integration of intrasubject variability in the workflow will be tested. The findings from this project will support the regulatory assessment of generic drug products. The developed and validated workflow will help to establish scientific and regulatory standards for supporting innovative development and performing virtual bioequivalence evaluation of these generic drug products.


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: 2025 ( Subtotal = $0 )
2025	2024	SIMULATIONS PLUS INC	800 PARK OFFICES DR STE 401	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Food and Drug Administration Research	000	2	6/19/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $249,392 )
2024	2024	SIMULATIONS PLUS INC	42505 10TH ST W STE 103	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	2	8/28/2024	NON-COMPETING CONTINUATION	$249,392
														Subtotal = $249,392

Issue Date FY: 2023 ( Subtotal = $249,640 )
2023	2023	SIMULATIONS PLUS INC	42505 10TH ST W STE 103	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	1	9/12/2023	NEW	$249,640
														Subtotal = $249,640

Grand Total All Awards = $499,032

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Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM-PBPK models

Award Number: U01FD007906

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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