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)

• The Effects of Formulation Factors and Actuator Design on Mometasone Furoate Metered Dose Inhaler In Vitro Aerosolization Performance

  Bielski, Elizabeth; Conti, Denise; Oguntimein, Oluwamurewa; Sheth, Poonam; Hallinger, Madeline; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Guenther

• Exploring the Relationship Between Suspension and Solution Metered Dose Inhaler Formulation Variables and Predicted Lung Deposition

  Schroeter, Jeffry; Sheth, Poonam; Hickey, Anthony; Asgharian, Bahman; Price, Owen; Holt, Jay; Conti, Denise; Saluja, Bhawana

• Fluticasone Pharmacokinetics: Meta-Analysis and Models

  Sakagami, Masahiro

• Influence of Formulation Factors on the Aerosol Performance of Suspension and Solution Metered Dose Inhalers: A Systematic Approach

  Sheth, Poonam; Sandell, Dennis; Conti, Denise; Holt, Jay; Hickey, Anthony; Saluja, Bhawana

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

  Dhapare, Sneha; Mohan, Abhinav; Newman, Bryan; Svensson, Marten; Elfman, Peter; Sandell, Dennis; Winner, Larry; Berger, Simon; Bulitta, Jurgen; Hochhaus, Guenther

• Current Inhalers Delivery very Small Doses to the Lower Tracheobronchial Airways: Assessment of Healthy and Constricted Lungs

  Longest, Worth

• Application of the Dose-Scale Method for Pharmacodynamic Bioequivalence Studies of Orally Inhaled Drug Products

  Kim, Stephanie; Lee, Sau; Lionberger, Robert

• Clinically Relevant in Vitro Performance Tests for Powder Inhalers

  Byron, Peter

• A Quasi-3D Compartmental Multi-Scale Approach to Detect and Quantify Diseased Regional Lung Constriction Using Spirometry Data

  Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej

• Modifications To The Multiple-Path Particle Dosimetry Model For Improved Predictions Of Lung Deposition From Metered Dose Inhalers

  Schroeter, Jeffry; Asgharian, Bahman; Price, Owen; Holt, Jay; Hickey, Anthony