CFD Models to aid the development of generic inhalation products
The summary for the CFD Models to aid the development of generic inhalation products grant is detailed below.
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CFD Models to aid the development of generic inhalation products: Current US Food and Drug Administration product specific guidance (PSG) bioequivalence (BE) recommendations for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically use a weight-of-evidence approach that includes in vitro studies, an in vivo pharmacokinetics (PK) study, and either an in vivo pharmacodynamics (PD) or comparative clinical endpoint (CCEP) study. To produce a generic MDI or DPI that is capable of passing all of these recommended studies, it would be useful to have an enhanced understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue. Computational fluid dynamics (CFD) is a technique capable of predicting these relationships between in vitro study metrics and regional lung deposition. The purpose of this grant announcement is to use CFD to produce verified and validated predictions of regional lung deposition for at least one currently marketed MDI or DPI in human upper and lower airways. Once predictions are appropriately verified and validated using either in vitro or in vivo data, a parameter sensitivity analysis will be conducted to assess the biopredictive capabilities of relevant in vitro studies. For DPIs, discrete element modeling (DEM) may be considered as a means for predicting the effects of agglomeration and deagglomeration of carrier-active pharmaceutical ingredient combination particles on regional deposition and the relationships of those phenomena with APSD. For MDIs, it is preferred that formulations considered include at least three components.
Federal Grant Title: | CFD Models to aid the development of generic inhalation products |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Consumer Protection Food and Nutrition Health |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | FOR-FD-20-023 |
Type of Funding: | Grant |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | August 23rd, 2021 |
Original Application Deadline: | August 23rd, 2021 |
Posted Date: | May 25th, 2021 |
Creation Date: | May 25th, 2021 |
Archive Date: | May 26th, 2021 |
Total Program Funding: | |
Maximum Federal Grant Award: | |
Minimum Federal Grant Award: | |
Expected Number of Awards: | 2 |
Cost Sharing or Matching: | No |
Last Updated: | May 25th, 2021 |
- Applicants Eligible for this Grant
- State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - 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 - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses
- Grant Announcement Contact
- Shashi Malhotra
Grants Management Specialist
[email protected] - Similar Government Grants
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