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,…
Active Cooperative Agreement Awarded Last action
- Award ID
- U01FD008303
- Recipient
-
University Of Texas At Austin UEI V6AFQPN18437 Part of University Of Texas System
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $1,098,018
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date 72% complete
- Funding agency
- Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
- Place of performance
- Austin, TX 78712, USA
Award details come from USAspending.gov.
Description
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.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $249,645 | |
| Amendment | $249,645 | |
| Amendment | $0 | |
| Amendment | $299,364 | |
| Original award | $299,364 |
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Certara UK LIMITED | $88,998 | |
| University Of Houston System | $237,144 |
Quick answers
Who received award U01FD008303?
U01FD008303 was awarded to University Of Texas At Austin by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 1, 2024.
How much is award U01FD008303 worth?
$1,098,018 has been obligated on U01FD008303.
Which agency awarded U01FD008303?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD008303, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).
On GovTribe
See this award's full record
- Every transaction and subaward
- The recipient's other awards and teaming partners
- Similar grant awards
- Ask GovTribe AI about this award