PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies
About This Grant
PBPK models are an effective tool to integrate the product characteristics and the physiology of the individual subject along with its variability within a population providing a means to simulate drug absorption and its subsequent disposition in the system without conducting in vivo pharmacokinetic studies. They have shown promise in supporting generic drug development and regulation. This opportunity solicits research proposals to expand the application of oral PBPK models to emerging issues in generic drug regulation that the Office of Generic Drugs (OGD) is currently facing. These issues include, but not limited to, 1) implementation of ICH guideline M9 (M9/M13)2) development of of ICH guideline M13 3) evaluation of alternative BE study designs motivated by public health emergencies such as to COVID-19The proposed research proposals are expected to include plans for the development and application of oral PBPK models that can simulate the results of bioequivalence studies and support OGD in addressing the above-mentioned issues. These simulations would include, but are not limited to, prediction of the results of fed BE studies, evaluation of excipient differences in the context of BCS III waiver requests, evaluation of dissolution differences in the context of BCS III waiver requests, identification of the most accurate, sensitive and reproducible analyte for BE determination, and evaluating modifications to BE study designs related to changes in the clinical trial environment due to public health emergencies.
Grant Summary
PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies is a Food and Drug Administration grant providing funding that varies by award for municipality. Applications are accepted on a rolling basis. Check eligibility and apply with FindGrants.
Focus Areas
Eligibility
How to Apply
Up to $0K
Rolling / Open
- 1Confirm your organization is eligible for PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies from Food and Drug Administration, checking organization type, location, and any population or project requirements.
- 2Gather the required documents and information, including your organization details, project plan, and budget figures.
- 3Draft your application narrative and budget addressing the funder's priorities and review criteria. FindGrants can draft each section for you to review and edit.
- 4Review every section against the requirements checklist, then export a submission-ready application pack and submit it to Food and Drug Administration before the deadline.
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PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies: Frequently Asked Questions
Who is eligible for the PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies?
PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies is offered by Food and Drug Administration and is generally open to municipality. It is open to organizations nationwide unless the funder specifies otherwise. Review the specific eligibility terms before applying, since funders set their own requirements around organization type, location, and the population or project being served.
How much funding does the PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies provide?
PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies provides an amount that varies by award per award from Food and Drug Administration. Actual award sizes depend on the scope of your project, available program funds, and the number of applicants, so build a budget that reflects realistic, allowable costs rather than the maximum figure.
When is the PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies deadline?
PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies accepts applications on a rolling or ongoing basis, so there is no single fixed deadline. Confirm current timing with the funder, Food and Drug Administration, before you apply, and submit as early as possible because rolling programs can close once funds are committed.
How do you apply for the PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies?
To apply for PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies, confirm your eligibility, gather the required documents, and prepare a narrative and budget that address the funder's priorities. FindGrants guides you step by step and can draft each section, then exports a submission-ready application pack for this grant from Food and Drug Administration.
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