The FDA offers a grant for the development, evaluation, and improvement of physiologically based absorption and pharmacokinetic models. This grant aims to support the generic drug guidance development, product development, and application review for complex drug products. Various subtopics include dermal, ocular, and lung absorption modeling, as well as modeling for non-biological complex parenteral drug products and nasally delivered products. Proposals should include model descriptions and validation plans, utilizing a diverse range of formulations for validation. The goal is to enhance the understanding of the interplay between product attributes and human physiology to ensure high-quality products and regulatory policies in complex drug areas.
Opportunity ID: 253186
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-012 |
| Funding Opportunity Title: | Physiologically Based Absorption and Pharmacokinetic Modeling and Simulation for Non-gastrointestinally Absorbed Drug Products In Humans |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Mar 28, 2014 |
| Last Updated Date: | Apr 01, 2014 |
| Original Closing Date for Applications: | Jun 02, 2014 |
| Current Closing Date for Applications: | Jun 02, 2014 |
| Archive Date: | Jul 02, 2014 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $200,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | City or township governments Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Independent school districts Nonprofits that do not have 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) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses County governments |
| Additional Information on Eligibility: | Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Evaluation of equivalence for complex drug products, such as locally acting drug products and non-biological complex parenteral drug products, is challenging. In general, the challenges for those drug products are to relate critical quality contributes to in vitro performance, to relate in vitro performance to in vivo performance, including drug distribution at the site of action and plasma drug distribution, and ultimately to relate in vitro drug performance to clinical performance. Physiologically based absorption and PK models capture the best current understanding of the complex interplay between product attributes and human physiology. Therefore they can aid FDA in developing regulatory science and policies in these complex areas and aid the generic industry in designing high quality products that meet public expectations for equivalence. Objectives:The objectives of this project are to develop, evaluate and improve physiologically based absorption and pharmacokinetic models for the following areas to support and facilitate generic drug guidance development, product development, and application review, in these areas.Subtopic 1: Physiologically based pharmacokinetic modeling and simulation of dermal absorptionSubtopic 2: Physiologically based pharmacokinetic modeling and simulation of ocular absorptionSubtopic 3: Physiologically based pharmacokinetic modeling and simulation for non-biological complex parenteral drug products (including liposomes, nanosuspension, micelles, microspheres, implants, and hydrogels)Subtopic 4: Physiologically based pharmacokinetic modeling and simulation of lung absorption via oral inhalationSubtopic 5: Physiologically based pharmacokinetic modeling and simulation of absorption from nasally delivered products (including nasal solutions, suspensions as well as nasal insufflation as a potential route of abuse) For each subtopic, the models should include but are not limited to formulation properties, drug substance properties, in vitro release mechanisms, physiology geometry, and microenvironment physiological parameters. The models should be based on the understanding of formulations, drug substance, physiology, mechanisms of drug delivery and mechanisms of drug transport. The final models should be able to predict drug concentration at the site of action, and drug plasma/blood concentration from various formulations.Proposals should at least include a description of the model, and model validation plans. In the proposal, applicants should indicate the formulations/drug products that will be used as model drug products for model validation and evaluation. If solutions are used in model development and validation, they should not be the only formulations used for model validation. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Edited Eligible Recipients and estimated program funding | Apr 01, 2014 | |
| Apr 01, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-012 |
| Funding Opportunity Title: | Physiologically Based Absorption and Pharmacokinetic Modeling and Simulation for Non-gastrointestinally Absorbed Drug Products In Humans |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Mar 28, 2014 |
| Last Updated Date: | Apr 01, 2014 |
| Original Closing Date for Applications: | Jun 02, 2014 |
| Current Closing Date for Applications: | Jun 02, 2014 |
| Archive Date: | Jul 02, 2014 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $200,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | City or township governments Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Independent school districts Nonprofits that do not have 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) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses County governments |
| Additional Information on Eligibility: | Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Evaluation of equivalence for complex drug products, such as locally acting drug products and non-biological complex parenteral drug products, is challenging. In general, the challenges for those drug products are to relate critical quality contributes to in vitro performance, to relate in vitro performance to in vivo performance, including drug distribution at the site of action and plasma drug distribution, and ultimately to relate in vitro drug performance to clinical performance. Physiologically based absorption and PK models capture the best current understanding of the complex interplay between product attributes and human physiology. Therefore they can aid FDA in developing regulatory science and policies in these complex areas and aid the generic industry in designing high quality products that meet public expectations for equivalence. Objectives:The objectives of this project are to develop, evaluate and improve physiologically based absorption and pharmacokinetic models for the following areas to support and facilitate generic drug guidance development, product development, and application review, in these areas.Subtopic 1: Physiologically based pharmacokinetic modeling and simulation of dermal absorptionSubtopic 2: Physiologically based pharmacokinetic modeling and simulation of ocular absorptionSubtopic 3: Physiologically based pharmacokinetic modeling and simulation for non-biological complex parenteral drug products (including liposomes, nanosuspension, micelles, microspheres, implants, and hydrogels)Subtopic 4: Physiologically based pharmacokinetic modeling and simulation of lung absorption via oral inhalationSubtopic 5: Physiologically based pharmacokinetic modeling and simulation of absorption from nasally delivered products (including nasal solutions, suspensions as well as nasal insufflation as a potential route of abuse) For each subtopic, the models should include but are not limited to formulation properties, drug substance properties, in vitro release mechanisms, physiology geometry, and microenvironment physiological parameters. The models should be based on the understanding of formulations, drug substance, physiology, mechanisms of drug delivery and mechanisms of drug transport. The final models should be able to predict drug concentration at the site of action, and drug plasma/blood concentration from various formulations.Proposals should at least include a description of the model, and model validation plans. In the proposal, applicants should indicate the formulations/drug products that will be used as model drug products for model validation and evaluation. If solutions are used in model development and validation, they should not be the only formulations used for model validation. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-012 |
| Funding Opportunity Title: | Physiologically Based Absorption and Pharmacokinetic Modeling and Simulation for Non-gastrointestinally Absorbed Drug Products In Humans |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 7 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 01, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 02, 2014 |
| Archive Date: | Jul 02, 2014 |
| Estimated Total Program Funding: | $2,000,000 |
| Award Ceiling: | $200,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Independent school districts For profit organizations other than small businesses City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments 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) County governments Small businesses |
| Additional Information on Eligibility: | Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Evaluation of equivalence for complex drug products, such as locally acting drug products and non-biological complex parenteral drug products, is challenging. In general, the challenges for those drug products are to relate critical quality contributes to in vitro performance, to relate in vitro performance to in vivo performance, including drug distribution at the site of action and plasma drug distribution, and ultimately to relate in vitro drug performance to clinical performance. Physiologically based absorption and PK models capture the best current understanding of the complex interplay between product attributes and human physiology. Therefore they can aid FDA in developing regulatory science and policies in these complex areas and aid the generic industry in designing high quality products that meet public expectations for equivalence.
Objectives: Subtopic 1: Physiologically based pharmacokinetic modeling and simulation of dermal absorption For each subtopic, the models should include but are not limited to formulation properties, drug substance properties, in vitro release mechanisms, physiology geometry, and microenvironment physiological parameters. The models should be based on the understanding of formulations, drug substance, physiology, mechanisms of drug delivery and mechanisms of drug transport. The final models should be able to predict drug concentration at the site of action, and drug plasma/blood concentration from various formulations. Proposals should at least include a description of the model, and model validation plans. In the proposal, applicants should indicate the formulations/drug products that will be used as model drug products for model validation and evaluation. If solutions are used in model development and validation, they should not be the only formulations used for model validation. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Related Documents
Folder 253186 Full Announcement-1 -> rfa-fd-14-012 physiologically based absorption and pharmacokinetic modeling and simulation for non-gastrointestinally absorbed drug products in humans (u01).pdf
Packages
| Agency Contact Information: | Gladys Melendez-Bohler Grants Management Specialist Phone 301-827-7175 Email: gladys.bohler@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| ADOBE-FORMS-C | RFA-FD-14-012 | PKG00194673 | May 01, 2014 | Jun 02, 2014 | View |
Package 1
Mandatory forms
253186 RR_SF424_2_0-2.0.pdf
253186 PHS398_ResearchPlan_2_0-2.0.pdf
253186 PHS398_CoverPageSupplement_2_0-2.0.pdf
253186 RR_Budget_1_3-1.3.pdf
253186 RR_KeyPersonExpanded_2_0-2.0.pdf
253186 RR_OtherProjectInfo_1_3-1.3.pdf
253186 PerformanceSite_2_0-2.0.pdf
Optional forms
253186 PlannedReport-1.0.pdf
253186 PHS398_CumulativeInclusionReport-1.0.pdf
253186 RR_SubawardBudget30_1_3-1.3.pdf
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