Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01)

The purpose of this project is to develop and implement a virtual bioequivalence trial simulation platform that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models developed to describe the absorption,

credit: Wingwire


distribution and elimination of active pharmaceutical ingredients formulated in complex and non-complex dosage forms administered via oral or non-oral routes.

The developed virtual bioequivalence trial simulation platform will be used to generate predictions on the in vivo drug product performance, to perform bioequivalence assessments between brand name and generic drug products and to inform regulatory decisions relating to generic drug development.

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: $94,976


Who's Eligible


Relevant Nonprofit Program Categories



Obtain Full Opportunity Text:
Link to Full Announcement

Additional Information of Eligibility:
Eligible Organizations Higher Education Institutions • Public/State Controlled Institutions of Higher Education • Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations • Small Businesses • For-Profit Organizations (Other than Small Businesses) Governments • State Governments • County Governments • City or Township Governments • Special District Governments • Indian/Native American Tribal Governments (Federally Recognized) • Indian/Native American Tribal Governments (Other than Federally Recognized) • Eligible Agencies of the Federal Government • U. S. Territory or Possession Other • Independent School Districts • Public Housing Authorities/Indian Housing Authorities • Native American Tribal Organizations (other than Federally recognized tribal governments) • Faith-based or Community-based Organizations • Regional Organizations • Non-domestic (non-U.S.) Entities (Foreign Institutions)

Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-18-018.html

Contact:


Agency Email Description:
Work Email

Agency Email:


Date Posted:
2018-04-20

Application Due Date:


Archive Date:
2018-07-20



Social Entrepreneurship
Spotlight



Role Small Business Philanthropy Play in Shaping Communities

Role Small Business Philanthropy Play in Shaping Communities
Philanthropy imparts a multitude of ways for small business owners to do social good –...



Human Services Jobs

  Social Work Jobs
  Executive Director Jobs
  Social Services Jobs
  Substance Abuse Jobs
  Fundraising & Development Jobs





More Federal Domestic Assistance Programs


Native American and Native Hawaiian Library Services | Native American Community Research, Demonstration, and Pilot Projects | Homeland Security, Research, Testing, Evaluation, and Demonstration of Technologies  | Snagging and Clearing for Flood Control | Native American/Native Hawaiian Museum Services Program  |  Site Style by YAML | Grants.gov | Grants | Grants News | Sitemap | Privacy Policy


Edited by: Michael Saunders

© 2004-2018 Copyright Michael Saunders