Enhancement and validation of in vitro - in vivo correlation method for long acting injectable drug products to accelerate their generic development
Ended Definitive Contract Awarded Last action
- Contract number
- 75F40121C00133
- Awardee
-
University Of Connecticut UEI WNTPS995QBM7 Part of Secretary Of State Connecticut
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $1,310,263
Award facts
- Opportunity
-
- FY21 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Solicitation · FDABAA2100123 · Posted Nov 20, 2020
- Contract value 100% obligated
- $1,310,263.00 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Basic Research
- Pricing
- Cost No Fee
- Place of performance
- Storrs, CT 06269, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Exercise an Option | $116,481 | |
| Other Administrative Action | $0 | |
| Original award | $1,193,782 |
About this award
The University of Connecticut (UConn) was awarded a $1,310,263 cost-no-fee definitive contract by the Food and Drug Administration (FDA) to enhance and validate in vitro-in vivo correlation (IVIVC) methods for long-acting injectable drug products to accelerate their generic development. The contract is part of the FDA's Broad Agency Announcement for Advanced Regulatory Science, which solicits research and development proposals across various areas to modernize regulatory science and support the agency's mission.
As a subcontractor under this contract, Simulations Plus Inc. will perform activities such as establishing preclinical IVIVC models, enhancing physiologically-based pharmacokinetic (PBPK) models, and validating IVIVC predictions for new formulations of long-acting injectable drug products. This work leverages Simulations Plus' expertise in pharmaceutical modeling and simulation software used for drug discovery, development, and regulatory assessment. The contract does not have a set-aside designation.
Subawards
| Subcontractor | Amount | Awarded |
|---|---|---|
| Simulations Plus Inc. | $238,000 |
Quick answers
Who was awarded contract 75F40121C00133?
75F40121C00133 was awarded to University Of Connecticut by Food and Drug Administration (Department of Health and Human Services) on September 24, 2021.
How much is contract 75F40121C00133 worth?
The government has obligated $1,310,263 on 75F40121C00133.
Was contract 75F40121C00133 competed?
The extent of competition for 75F40121C00133 was full and open competition. The government received 1 offer.
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