PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies — Food and Drug Administration funding opportunity
Food and Drug Administration · Federal agency

PBPK Models of Oral Absorption to Simulate the Results of Bioequivalence Studies

PBPK models are an effective tool to integrate the product characteristics and the physiology of the individual subject along with its variability within a population providing a means to simulate drug absorption and its...

96
match
Deadline Fixed Location Alabama Type grant Level Federal Open posted May 25, 2021
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Issued by: Food and Drug Administration.
  • About: PBPK models are an effective tool to integrate the product characteristics and the physiology of the individual subject along with its variability within a population providing a means to simulate drug absorption and its subsequent…
How was this generated?

The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

AI-generated. Always verify with the official source.

Deadline
Fixed

About this opportunity

PBPK models are an effective tool to integrate the product characteristics and the physiology of the individual subject along with its variability within a population providing a means to simulate drug absorption and its subsequent disposition in the system without conducting in vivo pharmacokinetic studies. They have shown promise in supporting generic drug development and regulation. This opportunity solicits research proposals to expand the application of oral PBPK models to emerging issues in generic drug regulation that the Office of Generic Drugs (OGD) is currently facing. These issues include, but not limited to, 1) implementation of ICH guideline M9 (M9/M13)2) development of of ICH guideline M13 3) evaluation of alternative BE study designs motivated by public health emergencies such as to COVID-19The proposed research proposals are expected to include plans for the development and application of oral PBPK models that can simulate the results of bioequivalence studies and support OGD in addressing the above-mentioned issues. These simulations would include, but are not limited to, prediction of the results of fed BE studies, evaluation of excipient differences in the context of BCS III waiver requests, evaluation of dissolution differences in the context of BCS III waiver requests, identification of the most accurate, sensitive and reproducible analyte for BE determination, and evaluating modifications to BE study designs related to changes in the clinical trial environment due to public health emergencies.

Funding agency

Tags

Want help applying?

Our specialists will check your eligibility, prepare the application, and walk you through every step — for free. Create a free account →

Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

We don't have application instructions on file yet — head straight to the official source.

Apply on agency site
Tip from our team:

Read the agency's eligibility checklist before you start — it's almost always shorter than the full NOFO and will tell you in 90 seconds whether to keep going.

Need help getting in touch with the right agency contact?

Create a free account and our specialists will guide you through the application end-to-end.

Source documents

View on agency site
Canonical NOFO, application packet, and forms
No supplemental documents yet.

Direct downloads (NOFO PDFs, application forms, FAQs) will appear here once our team attaches them. For now, the agency site has the canonical packet.

Citation details

Source systemgrants.gov
Source ID327615
PostedMay 25, 2021

Frequently asked questions

No FAQs yet.

Have a question about this fund? Sign in to open a ticket about this fund.