Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you have a validated GI dissolution model or expertise in predicting oral drug interactions, the FDA will fund development of a tool that directly impacts drug safety assessment.
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What this is
The U01 grant from FDA's Center for Drug Evaluation and Research focuses on developing and validating in vitro simulated GI dissolution models to better predict interaction risks for oral drugs—particularly those at high risk of problematic interactions. This is foundational pharmaceutical research aimed at improving drug safety assessment and reducing adverse events. Clinical trials are optional, making this suitable for labs focused on model development and validation. Applicants should have expertise in pharmaceutical sciences, gastrointestinal physiology simulation, and drug interaction mechanisms.
Who can apply
Specific eligibility not detailed in source material, but U01 grants typically support academic institutions, non-profits, small businesses, and commercial organizations conducting biomedical research. Applicants must demonstrate scientific and technical merit in pharmaceutical sciences or related fields. Check FDA SBIR/STTR eligibility if applying as a small business.
Topics: drug-drug interactions · food-drug interactions · in vitro dissolution modeling · oral drug products · gastrointestinal simulation · pharmaceutical safety
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.