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)

• A Semi-physiological Approach for Evaluating the Sensitivity of Pharmacokinetics to Detect Differences in Regional Lung Deposition of Orally-inhaled Drug Products (OIDPs)

  Kurumaddali, Abhinav; Amini, Elham; Drescher, Stefanie; Chen, Mongjen; Bulitta, Jurgen; Hochhaus, Gunther

• Inhalation Profile Modeling For Fluticasone Propionate Dry Powder Inhalers In Healthy Volunteers During A Four Way Crossover Bioequivalence Study

  Kurumaddali, Abhinav; Schilling, Uta; Chen, Mongjen; Jiao, Yuanyuan; Seay, Brandon; Baumstein, Sandra; Abu-Hasan, Mutasim; Conti, Denise; Oguntimein, Oluwamurewa; Delvadia, Renishkumar; Winner, Lawrence; Tabulov, Christine; Saluja, Bhawana; Bulitta, Jurge

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, A; Golshahi, L; Longest, W

• Evaluation of Bio-Relevant Mouth-Throat (MT) Models to Determine the Aerosol Deposition and Particle Size Distribution of QVAR Using Cascade Impactor

  Kaviratna, Anubhav; Liu, Xiaofei; Delvadia, Renishkumar; Guo, Changning

• A Multiscale Modeling Approach To Optimize Pulmonary Drug Delivery

  Kannan, Ravi; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• Factors Influencing Plume Characteristics of Flovent® HFA Following Passage through Bio-Relevant Mouth-Throat Models

  Kaisar, Md Abul; Dhapare, Sneha; Newman, Bryan; Svensson, Marten; Sandell, Dennis; Bulitta, Jurgen; Hochhaus, Gunther

• Evaluation of the Fast Screening Impactor with Dry Powder Inhalers

  Holtgrewe, Nicholas; Reed, Nathan; Kaviratna, Anubhav; Rodriguez, Jason; Guo, Changning

• The Influence Of Formulation Variables On The Performance Of A Beclomethasone Dipropionate Metered Dose Inhaler

  Holt, Jay; Hickey, Anthony; Vallorz-III, Ernest; Straughn, Kevin

• Influence Of Formulation Factors On Particle Size Distributions And Respiratory Tract Deposition Of Metered Dose Inhalers

  Holt, Jay; Vallorz-III, Ernest; Straughn, Kevin

• Investigation of the Effects of Physicochemical Properties of Dry Powder Inhalers on Batch-to-Batch Variability

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