Characterize skin physiology parameters utilized in dermal physiologically-based pharmacokinetic model development across different skin disease states (U01) | RFA FD 18 017

Opportunity Information: Apply for RFA FD 18 017

This government grant opportunity focuses on enhancing derma physiologically-based pharmacokinetic (PBPK) modeling to better understand skin physiology in various disease states. PBPK modeling, which has evolved significantly due to advancements in computational methods and experimental data, is a vital tool in drug development, especially for drugs applied topically to treat skin conditions.

The main goal is to identify skin physiology characteristics that differ between healthy individuals and those with skin diseases, and to incorporate this information into dermal PBPK models. This will improve the predictability of these models, facilitating virtual bioequivalence assessments between brand-name and generic dermatological products in situations where traditional in vivo studies are not feasible.

Key actions proposed for achieving this goal include:

1. Identifying essential skin physiology differences in various diseases, such as psoriasis and eczema, and gathering relevant data from credible sources. 2. Developing models that incorporate these characteristics, considering the variations in skin physiology across diverse populations, including differences linked to age, sex, and race.

3. Validating the models with appropriate datasets to ensure they accurately reflect the target populations and formulations.

4. Using the qualified models to simulate bioequivalence studies, determining the bioequivalence of generic products relative to their branded counterparts based on predicted outcomes.

Overall, this initiative aims to refine PBPK modeling for dermatological products, which is essential for understanding their absorption and effectiveness, ultimately benefiting regulatory processes and clinical applications.

• The Department of Health and Human Services, Food and Drug Administration in the food and nutrition sector is offering a public funding opportunity titled "Characterize skin physiology parameters utilized in dermal physiologically-based pharmacokinetic model development across different skin disease states (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on Mar 21, 2018.
• Applicants must submit their applications by May 29, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2025.)
• Each selected applicant is eligible to receive up to $250,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: 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 tribal governments), 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, Private institutions of higher education, Individuals, For profit organizations other than small businesses, Small businesses.

Apply for RFA FD 18 017

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