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)

• International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

  Lu, Dongmei; Lee, Sau; Lionberger, Robert; Choi, Stephanie; Adams, Wallace; Caramenico, Hoainhon; Chowdhury, Badrul; Conner, Dale; Katial, Rohit; Limb, Susam; Peters, John; Yu, Lawrence; Seymour, Sally; Li, Bing

• Demonstrating Q3 Structural Equivalence of Dry Powder Inhaler Blends: New Analytical Concepts and Techniques

  Price, Robert; Farias, Goncalo; Ganley, William; Shur, Jagdeep

• Validating CFD Predictions of Pharmaceutical Aerosol Deposition with In Vivo Data

  Tian, Geng; Hindle, Michael; Lee, Sau; Longest, Worth

• New Tools for Generic Orally Inhaled Drug Products to Maximize Prospects of Food and Drug Administration Approval

  Lionberger, Robert

• Optimization of the Transwell® System for Assessing the Dissolution Behavior of Orally Inhaled Drug Products through In Vitro and In Silico Approaches

  Amini, Elham; Kurumaddali, Abhinav; Bhagwat, Sharvari; Berger, Simon; Hochhaus, Gunther

• Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

  Price, Robert; Shur, Jagdeep; Ganley, William; Farias, Goncalo; Fotaki, Nikoletta; Conti, Denise; Delvadia, Renishkumar; Absar, Mohammad; Saluja, Bhawana; Lee, Sau

• Evaluation of Bioequivalence Criteria for Methacholine-Induced Bronchoprovocation: Bioequivalence Study of Albuterol Sulfate Metered Dose Inhalers

  Saluja, Bhawana; Delvadia, Renishkumar; Kim, Stephanie; Lee, Sau

• In Vitro Tests for Aerosol Deposition. VI: Realistic Testing with Different Mouth-Throat Models and In Vitro-In Vivo Correlations for a Dry Powder Inhaler, Metered Dose Inhaler, and Soft Mist Inhaler

  Wei, Xiangyin; Hindle, Michael; Kaviratna, Anubhav; Huynh, Bao; Delvadia, Renishkumar; Sandell, Dennis; Byron, Peter

• Effect of Device Design on the In Vitro Performance and Comparability for Capsule-Based Dry Powder Inhalers

  Shur, Jagdeep; Lee, Sau; Adams, Wallace; Lionberger, Robert; Tibbatts, James; Price, Robert

• Effects of Formulation and Actuator Design on Spray Pattern and Plume Geometry of Mometasone Furoate Metered Dose Inhalers

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