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(283)
• Posters(52)
• Presentations(126)
• Papers(105)

• In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple AnatomicallyCorrect Nasal Airway Models

  Golshahi, L; Manniello, M; Hosseini, S; Alfaifi, A; Schuman, T; Hindle, M; Longest, W; Sandell, D

• Acceptability Of Using Alternative Pk Metrics From Systemic Pharmacokinetic (Pk) Data To Inform Regional Deposition For Orally Inhaled Drug Products

  Feng, Kairui

• Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation

  Dytta, R; Kolanjiyil, A; Golshahi, L; Longest, W

• Characterizing the time-course of lung absorption via Population Pharmacokinetic Modeling

  Drescher, Stephanie

• Effects of Formulation and Actuator Design on Spray Velocity of Mometasone Furoate Metered Dose Inhalers

  Dhapare, S; Murphy, S; Sandell, D; Winner, L; Sheth, P; Hallinger, M; Svensson, M; Conti, D S; Oguntimein, O; Bulitta, J B; Hochhaus, G

• Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers (MDIs)

  Dhapare, S

• Demonstrating Bioequivalence with Inhalation Spray Drug Products

  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

• The Effects of Formulation Factors and Actuator Design on Spray Pattern and Plume Geometry of Mometasone Furoate Metered Dose Inhalers

  Dhapare, Sneha

• GDUFA Regulatory Science Initiatives for Generic Orally Inhaled and Nasal Drug Products

  Delvadia, Renishkumar