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Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed

ID: RFA-FD-24-005 • Type: Posted

Description

Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs.

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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Category of Funding
Agriculture
Consumer Protection
Food and Nutrition
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.103 - Food and Drug Administration Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 1/15/24 Food and Drug Administration posted grant opportunity RFA-FD-24-005 for Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed with funding of $300,000. The grant will be issued under grant program 93.103 Food and Drug Administration Research. It is expected that one grant will be made.

Timing

Posted Date
Jan. 15, 2024, 12:00 a.m. EST
Closing Date
April 8, 2024, 12:00 a.m. EDT Past Due
Last Updated
April 2, 2024, 7:46 a.m. EDT
Version
4
Archive Date
April 30, 2024

Eligibility

Eligible Applicants
Native American tribal governments (Federally recognized)
For profit organizations other than small businesses
Small businesses
Special district governments
City or township governments
County governments
Public housing authorities/Indian housing authorities
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
State governments
Public and State controlled institutions of higher education

Award Sizing

Ceiling
$300,000
Floor
Not Listed
Estimated Program Funding
$300,000
Estimated Number of Grants
1

Contacts

Contact
Terrin Brown Grantor
Contact Email
terrin.brown@fda.hhs.gov   Profile
Contact Phone
(240) 402-7610
Additional Information
RFA-FD-24-005 Funding Opportunity Announcement
Additional Information Site
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-005.html

Documents

Posted documents for RFA-FD-24-005

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