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)

• 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

• Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

  Lemerdy, Maxime; Tan, Mingliang; Babiskin, Andrew; Zhao, Liang

• Quality by Design Approach for Understanding the Critical Quality Attributes of Cyclosporine Ophthalmic Emulsion

  Rahman, Ziyaur; Xu, Xiaoming; Katragadda, Usha; Krishnaiah, Yellela; Yu, Lawrence; Khan, Mansoor

• Analytical Considerations for Measuring the Globule Size Distribution of Cyclosporine Ophthalmic Emulsions

  Petrochenko, Peter; Pavurala, Naresh; Wu, Yong; Wong, Sook Yee; Parhiz, Hamideh; Chen, Kang; Patil, Sharadrao; Qu, Haiou; Buoniconti, Patrick; Muhammad, Absar; Choi, Stephanie; Kozak, Darby; Ashraf, Muhammad; Cruz, Celia; Zheng, Jiwen; Xu, Xiaoming

• A Sensitive UPLC-APCI-MS/MS Method for the Determination of Dexamethasone and its Application in an Ocular Tissue Distribution Study in Rabbits Following Topical Administration

  Matta, Murali; Narayanasamy, Suresh; Thomas, Christopher; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Patel, Vikram; Rouse, Rodney