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

The Food and Drug Administration (FDA) is seeking applications to develop a methodology to integrate machine learning (ML) with computational fluid dynamics (CFD) models of orally inhaled drug products (OIDPs) to promote alternative bioequivalence (BE) studies. The goal is to enhance and accelerate the development and approval of generic OIDPs. • The application should focus on developing a methodology to integrate ML with CFD models of OIDPs. • The proposed approach should aim to alleviate limitations in using CFD, such as computational time and limited grid resolution. • The application should include a detailed plan for the development and validation of the integrated ML-CFD methodology. • The FDA expects the proposed methodology to enhance and accelerate the development and approval of generic OIDPs.