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)

• 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

• Deposition of Particles in the Alveolar Airways: Inhalation and Breath-Hold with Pharmaceutical Aerosols

  Longest, Worth

• In Vivo-Relevant Transwell Dish-Based Dissolution Testing for Orally Inhaled Corticosteroid Products

  Sakagami, Masahiro; Li, Hua; Venitz, Jugen

• In Vitro Investigations into Batch-to-Batch Variability in a Fluticasone Propionate and Salmeterol Dry Powder Inhaler

  Herpin, Matthew; Hefnawy, Amr; Smyth, Hugh

• Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA

  Wang, Zhong; Ahluwalia, Sharon; Newman, Bryan; Dhapare, Sneha; Zhao, Liang; Luke, Markham

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

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

• Evaluating Electrostatic Drug Deposition in Plastic Mouth-Throat Models with Budelin Novolizer

  Huynh, Bao; Wei, Xiangyin; Byron, Peter