GDUFA Research Outcomes

Ophthalmic-Otic Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the ophthalmic or otic route, including solutions, suspensions and other dosage forms.

• All(115)
• Posters(49)
• Presentations(26)
• Papers(40)

• Interplay Between Particle Flocculation and Dissolution Leading to Variation in Bioavailability and Clinical Performance of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming

• Impact of Particle Flocculation on Determination of Bioequivalence and Clinical Performance of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming

• Influence of polymeric excipients on the precision of particle size distribution measurements of suspensions using laser diffraction

  Smith, William; Vo, Anh; Bae, Jungeun; Wang, Yan; Qin, Bin; Xu, Xiaoming

• Influence of polymeric excipients on the precision of particle size distribution measurements of suspensions using laser diffraction

  Smith, William; Vo, Anh; Bae, Jungeun; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming

• Asymmetical-flow Field Fractionation to Assess the Impact of Manufacturing Process Variables on the Globule Size of Distribution of Cyclosporine Emulsions

  Qu, Haiou; Patel, Deval; Kozak, Darby; Walenga, Ross; Choi, Stephanie; Ashraf, Muhammad; Faustino, Patrick; Cruz, Celia; Xu, Xiaoming

• Asymmetric Flow Field Flow Fractionation as an Analytical Tool for the Size Based Separation and Characterization of Complex Ophthalmic Emulsions

  Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Yellela, Krishnaiah; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Determination of Globule Size Distribution of Cyclosporine Ophthalmic Emulsions using Asymmetric Flow Field Flow Fractionation

  Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Yellela, Krishnaiah; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study

  Qaraghuli, Farah Al; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera; Lemerdy, Maxime

• Physicochemical Characterization Of Tobradex And Tobradex ST Under Physiological Conditions

  Petrochenko, Peter; Hu, Ping; Wu, Yong; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen

• Impact of Process and Quality Control on the Physicochemical Properties of Tobramycin

  Patere, Shilpa; Newman, Bryan; Choi, Stephanie; Wang, Yan; Jay, Michael; Lu, Xiuling