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(162)
• Posters(65)
• Presentations(34)
• Papers(63)

• Understanding Drug Distribution and Release in Ophthalmic Emulsions

  Dong, Yixuan; Hengst, Leanna; Hunt, Robert; Patel, Deval; Vo, Anh; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Bi-Phasic Mass Transfer and Trans-Membrane Diffusion in Emulsions

  Dong, Yixuan; Qu, Haiou; Hengst, Leanna; Choi, Stephanie; Absar, Mohammad; Li, Vincent; Zheng, Jiwen; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Understanding Bi-phasic Mass Transfer and Trans-membrane Diffusion Kinetics in Emulsions

  Dong, Yixuan; Qu, Haiou; Hengst, Leanna; Choi, S; Absar, Mohammad; Li, Vincent; Zheng, Jiwen; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Effect of Formulation and Process Variables on the Properties of Cyclosporine Ophthalmic Ointments

  Dong, Yixuan; Qu, Haiou; Pavurala, Naresh; Wang, Jiang; Martinez, M; Fahmy, R; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Physicochemical Characterization Of Tobradex And Tobradex ST Under Physiological Conditions

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

• Importance of Comparative Unit Dose Concentration in the Evaluation of Complex Ophthalmic Suspension Product Quality

  Chen, Lynn; Manna, Soumyarwit; Petrochenko, Peter; Wu, Yong; Qin, Bin; Kozak, Darby; Zheng, Jiwen

• Effect of Particle Size and Viscosity of Ophthalmic Suspensions on Ocular Bioavailability

  Bourne, David; Vooturi, Sunil; Panda, Jiban; Choi, Stephanie; Kim, Hyewon; Yandrapu, Sarath; Kompella, Uday

• In Vitro – Ex Vivo Correlation of Drug Release from Semisolid Ophthalmic Ointments

  Bao, Quanying; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane

• Impact of Excipient Sources on In Vitro Drug Release Characteristics of Semisolid Ophthalmic Ointments

  Bao, Quanying; Shen, Jie; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane

• Manufacturing Differences on Physicochemical and In Vitro Release Characteristics of Semisolid Ophthalmic Ointments

  Bao, Quanying; Shen, Jie; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane