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

  Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, W

• Droplet Evaporation from a Solution-Based Metered Dose Inhaler: A Computational Approach

  Walenga, Ross; Conti, Denise; Oguntimein, Oluwamurewa; Delvadia, Renishkumar; Rygg, Alex; Babiskin, Andrew

• The Influence Of Formulation Variables On Mometasone Furoate pMDIs

  Sheth, Poonam; Sandell, Dennis; Svensson, Marten; Vallorz-III, Ernest; Sullivan, Jamie; Saluja, Bhawana; Conti, Denise

• A Dual-Internal Standard Lc-Uv-Msd Method To Improve Accuracy And Efficiency Of Characterizing Mometasone Furoate Mdis

  Sheth, Poonam; Vallorz-III, Ernest; Susick, Robert; Menzeleev, Ramil

• 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

• Characterization Of Particle Size Distributions And Respiratory Tract Deposition Of Albuterol Sulfate Metered Dose Inhalers

  Schroeter, Jeffry; Holt, Jay; Asgharian, Bahman; Bovet, Jean-Marc; Hickey, Anthony

• Coating Stages of Next Generation Impactor (NGI) When Testing Metered Dose Inhalers (MDIs) – A Comparative Study on US Commercial MDI Products

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

• Development of an In Vitro Permeation Test to Predict the In Vivo Performance of Naloxone Hydrochloride Nasal Spray Products

  Qarterman, Juliana; Al Ghabeish, Manar; Newman, Bryan; Walenga, Ross; Chopski, Steven; Zidan, Ahmed; Pavuluri, Venkateswara; Shakleya, Diaa; Li, Min; Ashraf, Muhammad

• Development of a Low-Volume In-Vitro Dissolution Method for Assessing Variability in Fine Particle Doses of Dry Powder Inhalers

  Nair, Varsha; Hefnawy, Amr; Herpin, Matthew; Feng, Kairui; Reed, Nathan; Ma, Tian; Bielski, Elizabeth; Dhapare, Sneha; Newman, Bryan; Boc, Susan; Smyth, Hugh

• In Vitro Batch-to-Batch Variability of Fluticasone Propionate and Salmeterol Dry Powder Inhalers

  Nair, Varsha; Hefnawy, Amr; Smyth, Hugh; Lee, Jieon; Feng, Kairui; Bielski, Elizabeth; Dhapare, Sneha; Newman, Bryan; Conti, Denise; Boc, Susan; Herpin, Matthew