Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional

Current U.S. Food and Drug Administration product-specific guidances for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically recommend using a weight-of-evidence approach for demonstrating bioequivalence (BE) that includes in vitro studies, an in vivo pharmacokinetics study, and either an in vivo pharmacodynamics or comparative clinical endpoint BE study.  To produce a generic MDI or DPI that can meet acceptance criteria from all these recommended studies, it would be useful to have an enhanced understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue.  Computational fluid dynamics (CFD) is a technique capable of predicting these relationships between in vitro study metrics and regional lung deposition.