This grant is for developing an advanced computational fluid dynamics (CFD) model to accurately predict total and regional lung deposition of orally inhaled drug products. The model will consider drug characteristics (aerodynamic particle size distribution) and physiological parameters (breathing patterns, airway geometry), predicting highly localized aerosol deposition from metered dose and dry powder inhalers. This research will enable a linked CFD-compartment model, crucial for assessing lung deposition’s impact on drug safety (systemic exposure) and efficacy (local delivery). Ultimately, this project enhances understanding of particle size-pharmacokinetics relationships, directly influencing bioequivalence policy for generic inhaled products, improving drug quality-by-design, dose accuracy, and setting clinically relevant product specifications.
Opportunity ID: 168013
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 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: | Independent school districts Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses City or township governments Special district governments Small businesses Public housing authorities/Indian housing authorities Nonprofits having 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) |
| 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: | Full Announcement RFA-FD-12-019 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Correction to Application Due Date and Award Budget. | May 17, 2012 | |
| Change to Estimated Total Program Funding and Award Ceiling. | May 17, 2012 | |
| May 08, 2012 |
DISPLAYING: Synopsis 3
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 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: | Independent school districts Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses City or township governments Special district governments Small businesses Public housing authorities/Indian housing authorities Nonprofits having 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) |
| 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: | Full Announcement RFA-FD-12-019 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 2
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 17, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 31, 2012 |
| Archive Date: | Jun 30, 2012 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) State governments Public and State controlled institutions of higher education City or township governments For profit organizations other than small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Small businesses Independent school districts County governments 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: | Full Announcement RFA-FD-12-019 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 1
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: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 08, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 31, 2012 |
| Archive Date: | Jun 30, 2012 |
| Estimated Total Program Funding: | $150,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education City or township governments For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Special district governments Small businesses Independent school districts County governments 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: | Full Announcement RFA-FD-12-019 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Related Documents
Folder 168013 Other Supporting Documents-SF424 (R&R) Guide General Adobe Version B 1 -> sf424_rr_guide_general_adobe_verb.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00119370 | May 01, 2012 | Jun 08, 2012 | View |
Package 1
Mandatory forms
168013 RR_SF424_1_2-1.2.pdf
168013 PerformanceSite_1_4-1.4.pdf
168013 RR_OtherProjectInfo_1_3-1.3.pdf
168013 RR_KeyPersonExpanded_1_2-1.2.pdf
168013 RR_Budget-1.1.pdf
168013 PHS398_CoverPageSupplement_1_4-1.4.pdf
168013 PHS398_ResearchPlan_1_3-1.3.pdf
168013 PHS398_Checklist_1_3-1.3.pdf
Optional forms
168013 RR_SubawardBudget30-1.2.pdf
168013 PHS_CoverLetter_1_2-1.2.pdf
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