Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products (U01)

FDA's CDER is seeking depositional data obtained with a computational modeling approach for small airway delivery to adults with orally inhaled drug products (OIDPs) that are indicated for management of asthma. Possible sources of intersubject variability include lengths and diameters of various airway segments, heterogeneous or homogeneous constriction, and inhalation patterns. An expected outcome is regional deposition data for reference listed drugs that can indicate whether or not the drug product targets small airways in asthmatic patients and the key product attributes that affects the deposition.