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)

• Quantitative Characterization of Circadian Rhythm of Pulmonary Function in Asthmatic Patients Treated with Inhaled Corticosteroids

  Zhou, Di; Li, Hongshan; Wang, Yaning; Hochhaus, Guenther; Sinha, Vikram; Zhao, Liang

• The Influence Of Formulation Variables On Mometasone Furoate pMDIs

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

• Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

  Lee, Jieon; Feng, Kairui; Conti, Denise; Walenga, Ross; Wientijes, Michael; Wang, Hezhen; Newman, Bryan; Han, Liangfeng; Dhapare, Sneha; Bielski, Elizabeth; Babiskin, Andrew; Wu, Fang; Donnelly, Mark; Kim, Myong-Jin; Jiang, Wenlei; Luke, Markham; Fang, Lanyan; Zhao, Liang

• Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?

  Hochhaus, Gunther; Chen, Mong Jen; Kurumaddali, Abhinav; Schilling, Uta; Jiao, Yuanyuan; Drescher, Stefanie; Amini, Elham; Kandala, Bhargava; Tabulov, Christine; Shao, Jie; Seay, Brandon; Abu-Hasan, Mutasim; Baumstein, Sandra; Winner, Lawrence; Shur, Jagdeep; Price, Robert; Hindle, Michael; Wei, Xiangyin; Carrasco, Cynthia; Sandell, Dennis; Oguntimein, Oluwamurewa; Kinjo, Minori; Delvadia, Renishkumar; Saluja, Bhawana; Lee, Sau; Conti, Denise; Bulitta, Jurgen

• Evaluation of the Fast Screening Impactor with Dry Powder Inhalers

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

• 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

• Predictive In Vitro Dissolution Methods for Orally Inhaled Drug Products

  Price, Robert

• 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