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.

• All(217)
• Posters(37)
• Presentations(91)
• Papers(89)

• 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

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly