PBPK Models to Aid the Development of Generic Dermatological Products

PBPK modeling and simulation tools have been extremely useful tool in the drug development process, in the interaction with regulatory agencies, and in decision making in the clinical setting.

The objective of this NOFO is to promote further enhancements to improve the predictive power of these

modeling and simulation tools and to expand their capabilities in leveraging observed data collected in vivo and in vitro data towards model development and validation.

Goals of this research could include:1) Incorporation of formulation attributes such as a.

viscosity impacting drug release and stratum corneum permeation, b.

Q1/Q2 information leveraged to predict evaporation profiles based on Q2 component) to improve the predictive power of the existing modeling tools.2) Incorporation of new or modification of existing formulation attributes that would allow predicting skin permeation for drug products with unique drug release technologies such as microneedles or iontophoresis3) Development of an in silico in vitro permeation testing module that may support formulation development strategies, formulation selection, inform in vivo PBPK model development by leveraging experimental IVPT data and conduct BE assessments between R and T drug products.

Further leverage this module to design IVPT studies that may be clinically relevant and discriminatory at the same time.4) Incorporation of novel approaches in accounting for excipient effects on skin permeation which may include parallel permeation for both API and excipient or identifying excipient-impacted permeation parameters for the API.5) Enhancements of skin physiology models to include skin metabolism with metabolite tracking (develop novel methodologies), enhancements on stratum corneum morphology such as protein binding, and corneocyte dimensions intended to improve prediction for lipophilic compounds).6) Generation of new experimental data as appropriate to support the other goals
Related Programs

Food and Drug Administration Research

Department of Health and Human Services

Agency: Department of Health and Human Services

Office: Food and Drug Administration

Estimated Funding: $4,000,000

Who's Eligible

Relevant Nonprofit Program Categories

Obtain Full Opportunity Text:
USFS Landscape Scale Restoration grants web page

Additional Information of Eligibility:
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U. S. Territory or Possession.

Full Opportunity Web Address:


Agency Email Description:

Agency Email:

Date Posted:

Application Due Date:

Archive Date:

Social Entrepreneurship

Philanthropy Shaping A New Miami

Many people, organizations and businesses in Miami are actively committed to philanthropy. As Javier Alberto Soto, president and CEO of the Miami Foundation, puts it, “Miami is home to a young, diverse demographic that’s looking for ways to get involved, ways to improve our community that aren’t traditional, like a formal gala.”

Not for Profit Jobs in Nebraska

  Executive Director Jobs
  Substance Abuse Jobs
  Program Director Jobs
  Executive Director Jobs
  Social Services Jobs

More Federal Domestic Assistance Programs

Promotion of the Humanities Fellowships and Stipends | Transportation Infrastructure Finance and Innovation Act (TIFIA) Program | Harold Rogers Prescription Drug Monitoring Program | Indian Health Service Educational Loan Repayment | Promoting the Cancer Surveillance Workforce, Education and Data Use |  Site Style by YAML | Grants.gov | Grants | Grants News | Sitemap | Privacy Policy

Edited by: Michael Saunders

© 2004-2022 Copyright Michael Saunders