forecast FOR-FD-24-005

Funding to validate in vitro GI models to predict food and drug interaction risks for high-risk oral ASD generic drugs

This grant opportunity aims to study the effectiveness of an in vitro gastrointestinal dissolution model to evaluate amorphous solid dispersion (ASD) drug products. The focus is on understanding how food and acid-reducing agents affect drug absorption, considering different formulations of drugs. By refining and validating this methodology, it seeks to predict in vivo outcomes and guide the re…

The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to dev…

Funding Source

Agency: Food and Drug Administration

Awards & funding

Award Ceiling: $500,000
Award Floor: $250,000

Eligibility

Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
Small businesses
State governments

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH…

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