Food and Drug Administration

Description

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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses

Contact

Shashi Malhotra <br/>Grants Management Specialist
shashi.malhotra@fda.hhs.gov