This department is offering a grant to evaluate and compare different in vitro release methods for liposomal drug products, aiming to enhance the regulatory review process for generic liposomal drug applications. The study will focus on assessing the robustness, formulation detection capabilities, and in vivo predictive power of various in vitro release methods using model liposomal drugs. By analyzing a range of factors and conditions, this research seeks to establish standardized and effective in vitro release assays, ultimately benefitting the public by improving access to high-quality generic liposomal drug products.
Opportunity ID: 253192
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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 7 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Jun 09, 2014 |
| Original Closing Date for Applications: | Jun 03, 2014 |
| Current Closing Date for Applications: | Jun 16, 2014 Correction to close date, to reflect a change in due date of application from June 1 to June 15, 2014. |
| Archive Date: | Jul 16, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) County governments Special district governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses State governments For profit organizations other than small businesses Independent school districts 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) Public housing authorities/Indian housing authorities City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products.Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following:a. Review available in vitro release methods for the selected model liposomal drug product(s).b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. Characterize physicochemical properties including mean particle size and distribution, surface charge, pH, shape, lamellarity and others.c. Conduct dissolution studies of prepared liposome formulations (including the marketed model product) with various in vitro release methods. Both conventional methods and innovative in vitro release study design can be explored. d. Vary in vitro release conditions and identify critical factors that affect the performance of each type of in vitro release method evaluated.e. Identify in vitro release methods which can distinguish liposome formulations with different in vitro characteristics. Use the in vitro release data together with animal data or human data to establish an in silico platform and explore in vitro in vivo correlation of selected liposomal drug product(s). |
| Link to Additional Information: | How to Apply |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 240-402-7565 Email:gladys.bohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Close date has been changed, to reflect a change in due date of application from June 1 to June 15, 2014. The close date is now June 16, 2014. | Jun 09, 2014 | |
| Correction to close date to reflect a change in due date of application from June to June 15, 2014. | Jun 09, 2014 | |
| Correction to close date to reflect the close date in the FOA | Jun 09, 2014 | |
| Update to Project Officer Phone #:
Nan Zheng, Ph.D. Update to Grants Management Officer/Specialist Phone #: Gladys Melendez (Bohler) |
Jun 09, 2014 | |
| Made a change to Eligible recipients; attached a | Apr 29, 2014 | |
| Changed RFA Number to reflect RFA-FD-14-016. | Apr 01, 2014 | |
| Apr 01, 2014 |
DISPLAYING: Synopsis 7
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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 7 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Jun 09, 2014 |
| Original Closing Date for Applications: | Jun 03, 2014 |
| Current Closing Date for Applications: | Jun 16, 2014 Correction to close date, to reflect a change in due date of application from June 1 to June 15, 2014. |
| Archive Date: | Jul 16, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) County governments Special district governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses State governments For profit organizations other than small businesses Independent school districts 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) Public housing authorities/Indian housing authorities City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products.Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following:a. Review available in vitro release methods for the selected model liposomal drug product(s).b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. Characterize physicochemical properties including mean particle size and distribution, surface charge, pH, shape, lamellarity and others.c. Conduct dissolution studies of prepared liposome formulations (including the marketed model product) with various in vitro release methods. Both conventional methods and innovative in vitro release study design can be explored. d. Vary in vitro release conditions and identify critical factors that affect the performance of each type of in vitro release method evaluated.e. Identify in vitro release methods which can distinguish liposome formulations with different in vitro characteristics. Use the in vitro release data together with animal data or human data to establish an in silico platform and explore in vitro in vivo correlation of selected liposomal drug product(s). |
| Link to Additional Information: | How to Apply |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 240-402-7565 Email:gladys.bohler@fda.hhs.gov |
DISPLAYING: Synopsis 6
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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 6 |
| Posted Date: | Jun 09, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 16, 2014 Correction to close date to reflect a change in due date of application from June to June 15, 2014. |
| Archive Date: | Jul 16, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Private institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products.Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following:a. Review available in vitro release methods for the selected model liposomal drug product(s).b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. Characterize physicochemical properties including mean particle size and distribution, surface charge, pH, shape, lamellarity and others.c. Conduct dissolution studies of prepared liposome formulations (including the marketed model product) with various in vitro release methods. Both conventional methods and innovative in vitro release study design can be explored. d. Vary in vitro release conditions and identify critical factors that affect the performance of each type of in vitro release method evaluated.e. Identify in vitro release methods which can distinguish liposome formulations with different in vitro characteristics. Use the in vitro release data together with animal data or human data to establish an in silico platform and explore in vitro in vivo correlation of selected liposomal drug product(s). |
| Link to Additional Information: | How to Apply |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 240-402-7565 Email:gladys.bohler@fda.hhs.gov |
DISPLAYING: Synopsis 5
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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 5 |
| Posted Date: | Jun 09, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 02, 2014 Correction to close date to reflect the close date in the FOA. |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Private institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products.Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following:a. Review available in vitro release methods for the selected model liposomal drug product(s).b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. Characterize physicochemical properties including mean particle size and distribution, surface charge, pH, shape, lamellarity and others.c. Conduct dissolution studies of prepared liposome formulations (including the marketed model product) with various in vitro release methods. Both conventional methods and innovative in vitro release study design can be explored. d. Vary in vitro release conditions and identify critical factors that affect the performance of each type of in vitro release method evaluated.e. Identify in vitro release methods which can distinguish liposome formulations with different in vitro characteristics. Use the in vitro release data together with animal data or human data to establish an in silico platform and explore in vitro in vivo correlation of selected liposomal drug product(s). |
| Link to Additional Information: | How to Apply |
| 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 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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 4 |
| Posted Date: | Jun 09, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 03, 2014 |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Private institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products.Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following:a. Review available in vitro release methods for the selected model liposomal drug product(s).b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. Characterize physicochemical properties including mean particle size and distribution, surface charge, pH, shape, lamellarity and others.c. Conduct dissolution studies of prepared liposome formulations (including the marketed model product) with various in vitro release methods. Both conventional methods and innovative in vitro release study design can be explored. d. Vary in vitro release conditions and identify critical factors that affect the performance of each type of in vitro release method evaluated.e. Identify in vitro release methods which can distinguish liposome formulations with different in vitro characteristics. Use the in vitro release data together with animal data or human data to establish an in silico platform and explore in vitro in vivo correlation of selected liposomal drug product(s). |
| Link to Additional Information: | How to Apply |
| 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 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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 3 |
| Posted Date: | Apr 29, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 03, 2014 |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Private institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities 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 Public and State controlled institutions of higher education Small businesses City or township governments |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products.Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following:a. Review available in vitro release methods for the selected model liposomal drug product(s).b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. Characterize physicochemical properties including mean particle size and distribution, surface charge, pH, shape, lamellarity and others.c. Conduct dissolution studies of prepared liposome formulations (including the marketed model product) with various in vitro release methods. Both conventional methods and innovative in vitro release study design can be explored. d. Vary in vitro release conditions and identify critical factors that affect the performance of each type of in vitro release method evaluated.e. Identify in vitro release methods which can distinguish liposome formulations with different in vitro characteristics. Use the in vitro release data together with animal data or human data to establish an in silico platform and explore in vitro in vivo correlation of selected liposomal drug product(s). |
| Link to Additional Information: | How to Apply |
| 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 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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: | Apr 01, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 03, 2014 |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.
Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products. Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following: |
| Link to Additional Information: | – |
| 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-16-016 |
| Funding Opportunity Title: | Evaluation of in vitro release methods for liposomal drug products |
| 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 1 |
| Posted Date: | Apr 01, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 03, 2014 |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The development of generic liposomal drug products is challenged by a lack of compendial or bio-relevant in vitro release methods. The traditional in vitro release method relies on dialyzing the liposomal formulation against a large volume of buffer. This method suffers from poor in vivo predictive power due to its inability to mimic the complex in vivo release conditions such as the large membrane pool present in systemic circulation or drug release conditions at the tumor sites or in the macrophages. Modifications to the traditional method include dialyzing against serum, serum protein solution, or surfactant solution and performing multiple stage dialyses. In addition, advances in separation techniques, such as filtration, centrifugation, and solid phase extraction, makes possible novel in vitro release assays in the presence of excess acceptor multilamellar or unilamellar vesicles. The robustness and predictive power of these methods have not been systemically evaluated or compared for specific type of liposomal drug products. The optimization and establishment of a standard in vitro release assay will advance the regulatory review of generic liposomal product applications.
Objectives: The purpose of this study is to evaluate different in vitro release methods for liposomal drug products and analyze their robustness, capability of detecting formulation differences, and predictive power for in vivo performance. This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products. Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following: |
| Link to Additional Information: | – |
| 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 253192 Full Announcement-2 -> RFA-FD-14-016 Evaluation of In Vitro Release Methods for Liposomal Drug Products (U01).pdf
Packages
| Agency Contact Information: | Gladys Melendez-Bohler Grants Management Specialist Phone 240-402-7565 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 |
|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-C | RFA-FD-14-016 | PKG00194665 | May 01, 2014 | Jun 16, 2014 | View |
Package 1
Mandatory forms
253192 RR_SF424_2_0-2.0.pdf
253192 PHS398_ResearchPlan_2_0-2.0.pdf
253192 PHS398_CoverPageSupplement_2_0-2.0.pdf
253192 RR_Budget_1_3-1.3.pdf
253192 RR_KeyPersonExpanded_2_0-2.0.pdf
253192 RR_OtherProjectInfo_1_3-1.3.pdf
253192 PerformanceSite_2_0-2.0.pdf
Optional forms
253192 PlannedReport-1.0.pdf
253192 PHS398_CumulativeInclusionReport-1.0.pdf
253192 RR_SubawardBudget30_1_3-1.3.pdf
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