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 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 …
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