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)

• 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

• Demonstrating Bioequivalence with Inhalation Spray Drug Products

  Dhapare, Sneha

• 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

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

  Delvadia, Renishkumar

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Considerations for Pre-ANDA Meeting Requests for Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Emerging Concepts and New Technologies for Bioequivalence of Orally Inhaled and Nasal Drug Products

  Conti, Denise

• Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products

  Conti, Denise

• Current Product-specific Guidances and Common Questions in Pre-ANDA Communications

  Conti, Denise