GDUFA Research Outcomes
Inhalation Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the inhalation route, including orally inhaled products.
-
The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance
Bielski, Elizabeth
-
Alternative BE Approaches and Considerations for Nasal Products
Boc, S
-
Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies
Boc, Susan
-
Opeing Remarks
Zhang, Lei
-
Factors Influencing Plume Characteristics of Metered Dose Inhalers (MDIs) Following Passage through Bio-relevant Mouth-Throat Models
Dhapare, S; Newman, B; Svensson, M; Elfman, P; Sandell, D; Winner, L; Bulitta, J; Hochhaus G
-
Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers (MDIs)
Dhapare, S
-
Factors Influencing Plume Characteristics of Metered Dose Inhalers (MDIs) Following Passage through Bio-relevant Mouth-Throat Models
Dhapare, S; Newman, B; Svensson, M; Elfman, P; Sandell, D; Winner, L; Bulitta, J; Hochhaus G
-
The Effects of Formulation Factors and Actuator Design on Spray Pattern and Plume Geometry of Mometasone Furoate Metered Dose Inhalers
Dhapare, Sneha
-
Factors Influencing Plume Characteristics of Metered Dose Inhalers (MDIs) Following Passage through Bio-relevant Mouth-Throat Models
Dhapare, Sneha; Newman, Bryan; Svensson, Marten; Elfman, Peter; Sandell, Dennis; Winner, Larry; Bulitta, Jurgen; Hochhaus, Gunther
-
Generic Drug Development For Respiratory Products, US Food And Drug Administration Update
Newman, Bryan