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)

• A Kinetic Approach to Determining Drug Distribution in Complex Biphasic Systems

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

• Understanding Drug Distribution and Release in Ophthalmic Emulsions through Quantitative Evaluation of Formulation-Associated Variables

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

• Engineering the Properties of Polymer Photonic Crystals with Mesoporous Silicon Templates

  Wang, Joanna; Lee, Gha; Kennard, Rhiannon; Barillaro, Giuseppe; Bisiewicz, Rachel; Cortez Lemus, Norma; Cao, Xiaoyu; Anglin, Emily; Park, Jennifer; Potocny, Andrea; Bernhard, Drew; Li, Jianlin; Sailor, Michael

• LC-MS/MS method for simultaneous quantification of dexamethasone and tobramycin in rabbit ocular biofluids

  Meng, Tuo; Kosmider, Leon; Chai, Guihong; Raynold, Aji Alex Moothedathu; Pearcy, Adam; Qin, Bin; Wang, Yan; Lu, Xiuling; Halquist, Matthew; Xu, Qingguo

• Effect of Particle Size and Viscosity of Suspensions on Topical Ocular Bioavailability of Budesonide, a Corticosteroid

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

• Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time

  Walenga, Ross; Babiskin, Andrew; Zhang, Xinyuan; Absar, Mohammad; Zhao, Liang; Lionberger, Robert

• Protocol for Evaluation of Topical Ophthalmic Drug Products in Different Compartments of Fresh Eye Tissues in a Rabbit Model

  Chockalingam, Ashok; Xu, Lin; Stewart, Sharron; Lemerdy, Maxime; Tsakalozou, Eleftheria; Fan, Jianghong; Patel, Vikram; Rouse, Rodney

• Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera

• Physicochemical Attributes and Dissolution Testing of Ophthalmic Ointments

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

• Evaluating Drug Distribution and Release in Ophthalmic Emulsions: Impact of Release Conditions

  Dong, Yixuan; Hengst, Leanna; Hunt, Robert; Feng, Xin; Kozak, Darby; Choi, Stephanie; Ashraf, Muhammad; Xu, Xiaoming