Scout | Validate an in vitro GI dissolution model to predict food and drug interaction risks for high-risk oral drugs (U01)

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Validate an in vitro GI dissolution model to predict food and drug interaction risks for high-risk oral drugs (U01)

This opportunity funds research to develop and validate an in vitro simulated gastrointestinal dissolution model to better predict how food and acid-reducing agents affect amorphous solid dispersion (ASD) oral drugs. The work aims to connect in vitro results to in vivo outcomes, guide which in vivo bioequivalence (BE) studies are needed, and support regulatory decisions to reduce failure risk …

Source

Agency: Food and Drug Administration

Award

Award Ceiling: $500,000

Award Floor: $250,000

Eligibility

government

industry:manufacturing

nonprofit

small_business

tribal

university

For profit organizations other than small businesses

Native American tribal governments (Federally recognized)

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

Private institutions of higher education

State governments

Keywords

in vitro gi model

gastrointestinal dissolution

food effect

acid reducing agents

amorphous solid dispersion

bioequivalence studies

drug interaction risk

Supporting Links

Documents

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