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)

• Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products

  Witzmann, Kimberly

• A Sensitivity Analysis of the Modified Chi-Square Ratio Statistic for Equivalence Testing of Aerodynamic Particle Size Distribution

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

• 1D Network Simulations for Evaluating Regional Flow and Pressure Distributions in Healthy and Asthmatic Human Lungs

  Choi, Sanghun; Yoon, Sujin; Jeon, Jichan; Zou, Chunrui; Choi, Jiwoong; Tawhai, Merryn; Hoffman, Eric; Delvadia, Renishkumar; Babiskin, Andrew; Walenga, Ross; Lin, Chinglong

• Predicting Pulmonary Pharmacokinetics from In Vitro Properties of Dry Powder Inhalers

  Bhagwat, Sharvari; Schilling, Uta; Chen, Mongjen; Wei, Xiangyin; Delvadia, Renishkumar; Absar, Mohammad; Saluja, Bhawana; Hochhaus, Guenther

• Effect of an Upstream Grid on the Fluidization of Pharmaceutical Carrier Powders

  Elserfy, Khalid; Kourmatzis, Agisilaos; Chan, Hak Kim; Walenga, Ross; Cheng, Shaokoon

• Assessment and Validation of a Hygroscopic Growth Model with Different Water Activity Estimation Methods

  O’shaughnessy, Patrick; Leblanc, Lawrence; Pratt, Alessandra; Altmaier, Ralph; Rajaraman, Prathish; Walenga, Ross; Lin, Chinglong

• Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

  Lee, Sau; Saluja, Bhawana; Garcia Arieta, Alfredo; Santos, Gustavo; Li, Ying; Lu, Sarah; Hou, Shuguang; Rebello, Juliet; Vaidya, Abhijit; Gogtay, Jaideep; Purandare, Shrinivas; Lyapustina, Svetlana

• Evaluation of Statistical Methods for Determining Equivalence of Aerodynamic Particle Size Distribution

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

• Pharmaceutical Aerosols Deposition Patterns from a Dry Powder Inhaler: Euler Lagrangian Prediction and Validation

  Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• Unraveling the Pulmonary Fate of Fluticasone and Friends: Meeting the Physiologic and Pharmacokinetic Challenges

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