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

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

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

This grant aims to improve prediction of food/drug interactions for high-risk oral drugs by using a lab model that mimics the gut to assess drug performance.

HHS-FDA$500,000Forecasted

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

Development of Models, New Approach Methodologies, and Biological Materials for Studying Human Health and Diseases (R21 Clinical Trial Not Allowed)

This grant funds innovative research to develop or improve broadly applicable models, materials, and methodologies for studying multiple body systems or diseases relevant to human health, excluding single disease or system studies.

HHS-NIH11Forecasted Feb 16, 2028$500,000Forecasted

Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)

This grant supports developing non-invasive imaging to measure how topical drugs penetrate the skin, aiming for a new way to test topical drug bioequivalence.

HHS-FDA$250,000Forecasted