Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01)

The summary for the Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01): The goal of this proposal is to develop a computational fluid dynamics (CFD) model of orally inhaled drug products that can account for drug product characteristics (aerodynamic particle size distribution, APSD) and physiological parameters (breathing pattern and airway geometry) on total and regional deposition in the lungs. Specifically, the CFD model will be capable of predicting highly localized deposition of pharmaceutically relevant polydisperse aerosols from metered dose inhalers (MDIs) and dry powder inhalers (DPIs). The results obtained in this study will be used in developing a linked CFD-compartment model that can predict the effects of lung deposition on safety (systemic exposure) and efficacy (local delivery) for locally acting orally inhaled drugs.This investigation constitutes a critical step toward a better understanding of relationships among APSD, pharmacokinetics (PK) and local delivery for orally inhaled drug products. The outcome of the project will directly have an impact on the bioequivalence (BE) policy development for the generic orally inhaled products. In addition, it will help to (1) develop a quality-by-design (QbD) tool that could be used to improve the performance of orally inhaled drugs during the product development, (2) make accurate dose predictions, and (3) set clinical relevant APSD specifications to ensure product quality, for these drug/device combination products.

Federal Grant Title:	Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01)
Federal Agency Name:	Food and Drug Administration
Grant Categories:	Consumer Protection Health Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-12-019
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Jun 08, 2012
Original Application Deadline:	May 31, 2012
Posted Date:	Apr 27, 2012
Creation Date:	May 17, 2012
Archive Date:	Jun 30, 2012
Total Program Funding:	$300,000
Maximum Federal Grant Award:	$150,000
Minimum Federal Grant Award:	$0
Expected Number of Awards:	1
Cost Sharing or Matching:	No

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 - Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility: Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the FDA Grants Policy Statement, are allowed.
Grant Announcement Contact: Lisa Ko Grants Management Specialist
[email protected] [[email protected]]
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