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 funding opportunity aims to advance the development and validation of an in vitro simulated gastrointestinal dissolution model to evaluate the performance of amorphous solid dispersion drug products under clinically relevant conditions, particularly in the presence of food and acid-reducing agents. The initiative focuses on creating a mechanistic in vitro methodology that can predict in vivo behavior, helping to clarify how formulation and manufacturing differences between test and reference listed drugs affect absorption profiles. The ultimate goal is to establish a reliable predictive tool that correlates in vitro results with clinical outcomes, enabling more informed decisions regarding the design of bioequivalence studies and reducing the risk of therapeutic failure in high-risk generic oral drugs. The approach seeks to improve regulatory decision-making by providing a scientifically robust framework to assess food-drug and drug-drug interaction risks without always requiring in vivo trials. This effort is led by the Food and Drug Administration under the Department of Health and Human Services and is open to clinical trials on a voluntary basis. The opportunity was posted on November 24, 2023, with Terrin Brown as the designated point of contact for inquiries, providing an email and phone number for potential applicants seeking further information. The initiative is structured as a U01 grant mechanism, emphasizing a partnership between researchers and regulatory agencies to enhance the predictability and safety of oral drug products in real-world use scenarios.