Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD)

The Food and Drug Administration (FDA) is seeking to conduct a small in vivo study using impulse oscillometry (IOS) and spirometry endpoints to assess the treatment effect of an orally inhaled drug product (OIDP). The study aims to develop a computational fluid dynamics (CFD) model to better understand the applicability of IOS endpoints for generic product comparison with the reference product. The key aspects of this opportunity include: • The use of IOS and spirometry endpoints to assess lung function • The development of a CFD model to understand the applicability of IOS endpoints • The comparison of generic OIDPs with the reference product • The study's objective is to conduct a small in vivo study and develop a CFD model • The FDA is seeking applicants from various organizations, including public housing authorities, non-profits, and for-profit organizations.