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)

• A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution

  Weber, Benjamin; Hochhaus, Guenther; Adams, Wallace; Lionberger, Robert; Li, Bing; Tsong, Yi; Lee, Sau

• Evaluation of Bio-Relevant Mouth-Throat Models for Characterization of Metered Dose Inhalers

  Kaviratna, Anubhav; Tian, Geng; Liu, Xiaofei; Delvadia, Renishkumar; Lee, Sau; Guo, Changning

• Effect of Device Design and Formulation on the In Vitro Comparability for Multi-Unit Dose Dry Bowder Inhalers

  Shur, Jagdeep; Saluja, Bhawana; Lee, Sau; Tibbatts, James; Price, Robert

• Development of a Stochastic Individual Path (SIP) Model for Predicting the Deposition of Pharmaceutical Aerosols: Effects of Turbulence, Polydisperse Aerosol Size, and Evaluation of Multiple Lung Lobes

  Longest, Worth; Tian, Geng; Delvadia, Renishkumar; Hindle, Michael

• 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

• 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

• Fluticasone Pharmacokinetics: Meta-Analysis and Models

  Sakagami, Masahiro

• 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