FDA: Enhancing Safety and Efficacy of Orally Inhaled Drug Products Grant

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The Food and Drug Administration is offering a grant to develop a computational fluid dynamics (CFD) model for orally inhaled drug products. The model will focus on predicting lung deposition based on aerodynamic particle size distribution and physiological parameters. The goal is to improve the bioequivalence policy for generic inhaled products, enhance product development through a quality-by-design tool, and set APSD specifications. This grant aims to advance understanding of APSD, pharmacokinetics, and local delivery in order to optimize the performance of inhaled drugs and ensure product quality.

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Opportunity ID: 168013

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General Information

Document Type:: Grants Notice
Funding Opportunity Number:: RFA-FD-12-019
Funding Opportunity Title:: Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01)
Opportunity Category:: Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity:: Consumer Protection
Category Explanation::
Expected Number of Awards:: 1
Assistance Listings Number(s):: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement:: No
Version:: Synopsis 3
Posted Date:: Apr 27, 2012
Last Updated Date:: May 17, 2012
Original Closing Date for Applications:: May 31, 2012
Current Closing Date for Applications:: Jun 08, 2012
Archive Date:: Jun 30, 2012
Estimated Total Program Funding:: $ 300,000
Award Ceiling:: $150,000
Award Floor:: $0

Eligibility

Eligible Applicants:: Native American tribal organizations (other than Federally recognized tribal governments)
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.

Additional Information

Agency Name:: Food and Drug Administration
Description:: 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.
Link to Additional Information::
Grantor Contact Information:: If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version Modification Description Updated Date
Synopsis 3 Correction to Application Due Date and Award Budget. May 17, 2012
Synopsis 2 Change to Estimated Total Program Funding and Award Ceiling.
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings: 93.103
Competition ID:
Competition Title:
Opportunity Package ID: PKG00119370
Opening Date: May 01, 2012
Closing Date: Jun 08, 2012
Agency Contact Information:: Lisa Ko
Who Can Apply:: Organization Applicants
mendatory_forms SF424 (R & R) [V1.2]
Project/Performance Site Location(s) [V1.4]
Research And Related Other Project Information [V1.3]
Research And Related Senior/Key Person Profile (Expanded) [V1.2]
Research & Related Budget [V1.1]
PHS 398 Cover Page Supplement [V1.4]
PHS 398 Research Plan [V1.3]
PHS 398 Checklist [V1.3]
optional_forms R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2]
PHS Cover Letter [V1.2]

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