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Quantify the expression of metabolizing enzymes and transporter proteins in lung, eye and skin tissue in relevant animal models and humans
The purpose of this funding opportunity is to systematically quantify the protein levels of potential metabolizing enzymes and transporters in rabbit eye and human eye tissue, human skin tissue, or human lung tissue using most advanced techniques available.
Subsequently, the experimental data
collected from this study will be implemented into existing modeling platforms to allow for virtual BE assessments locally and systemically for the parent and its pharmacologically active metabolite (for example, prodrugs where it may be important to track both the parent and the active metabolite).
Upon the successful completion of this research, it is expected that the implemented enhancements will improve the predictive power of PBPK models that will be utilized to inform decisions on generic ophthalmic, dermal, and orally inhaled drug product development and to perform virtual BE assessments in support of regulatory decisions.
Subsequently, the experimental data
collected from this study will be implemented into existing modeling platforms to allow for virtual BE assessments locally and systemically for the parent and its pharmacologically active metabolite (for example, prodrugs where it may be important to track both the parent and the active metabolite).
Upon the successful completion of this research, it is expected that the implemented enhancements will improve the predictive power of PBPK models that will be utilized to inform decisions on generic ophthalmic, dermal, and orally inhaled drug product development and to perform virtual BE assessments in support of regulatory decisions.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $11,500,000
Office: Food and Drug Administration
Estimated Funding: $11,500,000
Who's Eligible
Obtain Full Opportunity Text:
Link to Opportunity at www.state.gov
Additional Information of Eligibility:
States with State Offices of Rural Health are eligible to apply.
Only one applicant from each state is eligible, based on the designation of the governor.
Full Opportunity Web Address:
https://www.state.gov/funding-opportunities/funding-opportunity-announcements/
Contact:
Agency Email Description:
shashi.malhotra@fda.hhs.gov
Agency Email:
Date Posted:
2021-05-25
Application Due Date:
Archive Date:
2021-05-26
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