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)

• Influence of Excipients on Physicochemical Characteristics of Ocular Semisolid Formulations and Their In Vitro Drug Release

  Patere, Shilpa; Sutthanut, khaetthareeya; Newman, Bryan; Choi, Stephanie; Jay, Michael; Lu, Xiuling

• Preparation And Evaluation Of Difluprednate Topical Ocular Emulsions

  Palakurthi, Srinath; Cai, Defu; Qiu, Jiang; Absar, Mohammad; Choi, Stephanie

• Membrane-Drug Binding and its Impact on In Vitro Release of Dexamethasone

  Mekjaruskul, Catheleeya; Beringhs, Andre; Luo, Wei Chung; Xu, Qingguo; Halquist, Matthew; Qin, Bin; Wang, Yan; Lu, Xiuling

• Dexamethasone Degradation During In Vitro Release From An Intravitreal Implant

  Matter, Brock; Ghaffari, Alireza; Bourne, David; Wang, Yan; Choi, Stephanie; Kompella, Uday

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

  Le Merdy, Maxime; Zheng, Yujuan; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Zhao, Liang

• Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

  Le Merdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang

• Application of Ocular Physiologically Based Pharmacokinetic Modeling to Understand the Impact of Particle Size and Viscosity on Ophthalmic Bioavailability of Tobradex ST Suspension in Rabbits

  Lemerdy, Maxime; Tsakalozou, Eleftheria; Choi, Stephanie; Kim, Myongjin; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Rouse, Rodney; Matta, Murali; Zhao, Liang; Lionberger, Robert; Fan, Jianghong

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

  Le Merdy, Maxime; Lukacova, Viera; Tan, Ming-Liang; Babiskin, Andrew; Zhao, Liang

• Impact of Changes in Ophthalmic Emulsion Globule Size Distribution and Viscosity on Tear Film Thickness and Menisci Characteristics

  Kumar, Sandeep; Cook, Nicholas; Gum, Glenwood; Manza, Linda; Naageshwaran, Vatsala; Lyulkin, Mathew; Xu, Xiaoming; Patel, Deval; Qu, Haiou; Walenga, Ross; Tan, Ming Liang; Babiskin, Andrew; Kaisar, Mohmmad Abul

• Towards Development of In Vitro Drug Release Methods for Difluprednate Ophthalmic Emulsion

  Hidau, Mahendra; Mehra, Neelesh; Absar, Mohammad; Choi, Stephanie; Potter, David; Palakurthi, Srinath