The FDA is offering a grant to support research in pharmacometric modeling and simulation for evaluating generic drugs. This grant focuses on developing quantitative models for population pharmacokinetic, pharmacodynamic, and dose-toxicity modeling, as well as evaluating generic drug substitutability and post-marketing risk assessment. The objective is to enhance the ANDA review process by utilizing computational tools to classify drugs with narrow therapeutic index, assess post-market risks, and determine bioequivalence criteria based on partial AUCs. Researchers can apply for separate proposals covering subtopics such as NTI drugs, generic substitutability, and partial AUC evaluation.
Opportunity ID: 253187
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-011 |
| Funding Opportunity Title: | Pharmacometric Modeling and Simulation for Generic Drugs Evaluation |
| 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: | $1,250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | County governments Private institutions of higher education City or township governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Small businesses Special district governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Computational modeling and simulation is one of the priority areas of Fiscal Year 14 GDUFA (Generic Drug User Fee Act) Regulatory Research program. It is essential to developing a modern ANDA (Abbreviated New Drug Application) review process that fully utilizes available computational and analytical tools. The focus of this FOA/RFA is to utilize pharmacometric modeling and simulation and develop quantitative methodology for generic drugs evaluation in several areas.Objectives:The objectives of this project are to develop quantitative models for generic drugs evaluation in the following areas:1. Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The goal is to develop models and modeling approaches that will help FDA classify drugs as having a narrow therapeutic index and identify those products that have a clinical use profile that requires tighter control of product quality and equivalence attributes.2. Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints.3. Pharmacometric modeling and simulation for partial AUC (area under the concentration vs. time curve) as bioequivalence criteria. The goal is to develop modeling and simulation tools that will aid FDA in identifying which generic drug products require greater degrees of pharmacokinetic profile similarity in order to assure therapeutic equivalence.Detailed Description:Applicants who wish to apply for more than one subtopic should submit separate proposals for each subtopic as listed below: Subtopic 1: Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs.The objective of this subtopic is to develop population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The quantitative model will be used to (1) define whether the drug candidate is belonged to NTI drugs, and (2) evaluate bioequivalence criteria for NTI drugs.Subtopic 2: Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment.The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate generic substitutability to address concerns about generic drug substitutability and for post marketing risk assessment. The suggested model drug products include but are not limited to antiepileptic drugs, attention deficit hyperactivity disorder drugs, and antidepressants.Subtopic 3: Pharmacometric modeling and simulation for partial AUCs (area under the concentration vs. time curve) as bioequivalence criteria.The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate partial AUCs as bioequivalence criteria. Some examples of specific questions to answer are (1) whether partial AUCs are needed for these drug products, (2) what are the appropriate partial AUCs for evaluation of bioequivalence. |
| 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 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-14-011 |
| Funding Opportunity Title: | Pharmacometric Modeling and Simulation for Generic Drugs Evaluation |
| 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: | $1,250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | County governments Private institutions of higher education City or township governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Small businesses Special district governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Computational modeling and simulation is one of the priority areas of Fiscal Year 14 GDUFA (Generic Drug User Fee Act) Regulatory Research program. It is essential to developing a modern ANDA (Abbreviated New Drug Application) review process that fully utilizes available computational and analytical tools. The focus of this FOA/RFA is to utilize pharmacometric modeling and simulation and develop quantitative methodology for generic drugs evaluation in several areas.Objectives:The objectives of this project are to develop quantitative models for generic drugs evaluation in the following areas:1. Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The goal is to develop models and modeling approaches that will help FDA classify drugs as having a narrow therapeutic index and identify those products that have a clinical use profile that requires tighter control of product quality and equivalence attributes.2. Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints.3. Pharmacometric modeling and simulation for partial AUC (area under the concentration vs. time curve) as bioequivalence criteria. The goal is to develop modeling and simulation tools that will aid FDA in identifying which generic drug products require greater degrees of pharmacokinetic profile similarity in order to assure therapeutic equivalence.Detailed Description:Applicants who wish to apply for more than one subtopic should submit separate proposals for each subtopic as listed below: Subtopic 1: Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs.The objective of this subtopic is to develop population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The quantitative model will be used to (1) define whether the drug candidate is belonged to NTI drugs, and (2) evaluate bioequivalence criteria for NTI drugs.Subtopic 2: Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment.The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate generic substitutability to address concerns about generic drug substitutability and for post marketing risk assessment. The suggested model drug products include but are not limited to antiepileptic drugs, attention deficit hyperactivity disorder drugs, and antidepressants.Subtopic 3: Pharmacometric modeling and simulation for partial AUCs (area under the concentration vs. time curve) as bioequivalence criteria.The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate partial AUCs as bioequivalence criteria. Some examples of specific questions to answer are (1) whether partial AUCs are needed for these drug products, (2) what are the appropriate partial AUCs for evaluation of bioequivalence. |
| 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-14-011 |
| Funding Opportunity Title: | Pharmacometric Modeling and Simulation for Generic Drugs Evaluation |
| 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: | $2,500,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | $150,000 |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses County governments Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education City or township governments Independent school districts Native American tribal governments (Federally recognized) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments |
| Additional Information on Eligibility: | Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Computational modeling and simulation is one of the priority areas of Fiscal Year 14 GDUFA (Generic Drug User Fee Act) Regulatory Research program. It is essential to developing a modern ANDA (Abbreviated New Drug Application) review process that fully utilizes available computational and analytical tools. The focus of this FOA/RFA is to utilize pharmacometric modeling and simulation and develop quantitative methodology for generic drugs evaluation in several areas.
Objectives: The objectives of this project are to develop quantitative models for generic drugs evaluation in the following areas: 1. Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The goal is to develop models and modeling approaches that will help FDA classify drugs as having a narrow therapeutic index and identify those products that have a clinical use profile that requires tighter control of product quality and equivalence attributes. 2. Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints. 3. Pharmacometric modeling and simulation for partial AUC (area under the concentration vs. time curve) as bioequivalence criteria. The goal is to develop modeling and simulation tools that will aid FDA in identifying which generic drug products require greater degrees of pharmacokinetic profile similarity in order to assure therapeutic equivalence. Detailed Description: Applicants who wish to apply for more than one subtopic should submit separate proposals for each subtopic as listed below: Subtopic 1: Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The objective of this subtopic is to develop population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The quantitative model will be used to (1) define whether the drug candidate is belonged to NTI drugs, and (2) evaluate bioequivalence criteria for NTI drugs. Subtopic 2: Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate generic substitutability to address concerns about generic drug substitutability and for post marketing risk assessment. The suggested model drug products include but are not limited to antiepileptic drugs, attention deficit hyperactivity disorder drugs, and antidepressants. Subtopic 3: Pharmacometric modeling and simulation for partial AUCs (area under the concentration vs. time curve) as bioequivalence criteria. The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate partial AUCs as bioequivalence criteria. Some examples of specific questions to answer are (1) whether partial AUCs are needed for these drug products, (2) what are the appropriate partial AUCs for evaluation of bioequivalence. |
| 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 253187 Full Announcement-1 -> rfa-fd-14-011 pharmacometric modeling and simulation for generic drugs evaluation (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 |
|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-C | RFA-FD-14-011 | PKG00194672 | May 01, 2014 | Jun 02, 2014 | View |
Package 1
Mandatory forms
253187 RR_SF424_2_0-2.0.pdf
253187 PHS398_ResearchPlan_2_0-2.0.pdf
253187 PHS398_CoverPageSupplement_2_0-2.0.pdf
253187 RR_Budget_1_3-1.3.pdf
253187 RR_KeyPersonExpanded_2_0-2.0.pdf
253187 RR_OtherProjectInfo_1_3-1.3.pdf
253187 PerformanceSite_2_0-2.0.pdf
Optional forms
253187 PlannedReport-1.0.pdf
253187 PHS398_CumulativeInclusionReport-1.0.pdf
253187 RR_SubawardBudget30_1_3-1.3.pdf
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