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

Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional

This grant aims to create PBPK models for long-acting injectable suspensions and implants, predicting drug release by linking formulation attributes to in-vivo performance.

HHS-FDA$300,000Forecasted

Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed

This grant aims to combine machine learning and computational fluid dynamics to improve generic inhaled drug development and approval through alternative bioequivalence studies.

HHS-FDAForecasted

Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed

This grant seeks to develop AI/ML models using real-world data to monitor clinical outcomes when patients switch between complex generics and brand-name drugs.

HHS-FDA$300,000Forecasted

Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed

This grant aims to identify drug and formulation factors causing alcohol-induced rapid release from modified-release drugs, improving testing and development for safer generics.

HHS-FDA$250,000Forecasted

Enhancing Mechanistic Research on Precision Probiotic Therapies (R33 Clinical Trial Optional)

Accelerate precision probiotic therapies by identifying person-specific features affecting probiotic responses to enhance clinical outcomes.

HHS-NIH11Due Jun 2, 2027