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(147)
• Posters(63)
• Presentations(30)
• Papers(54)

• 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

• Impact of Membranes on In Vitro Release Assessment: a Case Study Using Dexamethasone

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

• General Pharmacokinetic Model for Topically Administered Ocular Drug Dosage Forms

  Deng, Feng; Ranta, Veli Pekka; Kidron, Heidi; Urtti, Arto

• Influence of Manufacturing Process Variables on the Properties of Ophthalmic Ointments of Tobramycin

  Patere, Shilpa; Newman, Bryan; Wang, Yan; Choi, Stephanie; Vora, Sahil; Ma, Anson; Jay, Michael; Lu, Xiuling

• Factors affecting the particle size distribution and rheology of brinzolamide ophthalmic suspensions

  Vo, Anh; Feng, Xin; Patel, Deval; Mohammad, Adil; Kozak, Darby; Choi, Stephanie; Ashraf, Muhammad; Xu, Xiaoming

• Self-Reporting Photoluminescent Porous Silicon Microparticles for Drug Delivery

  Wang, Joanna; Kumeria, Tushar; Bezem, Maria; Wang, Jian; Sailor, Michael

• Safety and Toxicity of Nanomaterials for Ocular Drug Delivery Applications

  Mehra, Neelesh; Cai, Defu; Kuo, Lih; Hein, Travis; Palakurthi, Srinath