CFD Models to aid the development of generic inhalation products

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Opportunity ID:328700
Opportunity Number:FOR-FD-20-023
Opportunity Title:CFD Models to aid the development of generic inhalation products
Opportunity Category:Discretionary
Opportunity Category Explanation:
Funding Instrument Type:Grant
Category of Funding Activity:Consumer Protection
Food and Nutrition
Health
Category Explanation:
CFDA Number(s):93.103
Eligible Applicants: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
Additional Information on Eligibility:
Agency Code:HHS-FDA
Agency Name:Department of Health and Human Services
Food and Drug Administration
Posted Date:Aug 17, 2020
Last Updated Date:Aug 17, 2020
Estimated Synopsis Post Date:
Fiscal Year:2021
Award Ceiling:
Award Floor:
Estimated Total Program Funding:
Expected Number of Awards:2
Description: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.
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