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)

• 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

• Dexamethasone Degradation in Aqueous Medium and Implications for Correction of In Vitro Release from Sustained Release Delivery Systems

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

• Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products

  Lionberger, Robert

• In Vitro Release Testing Method Development for Ophthalmic Ointments

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

• Analyzing ophthalmic suspension particle size distributions using laser diffraction: Placebo background subtraction method

  Vo, Anh; Feng, Xin; Smith, William; Zhu, Dongkai; Patel, Mehulkumar; Kozak, Darby; Wang, Yan; Zheng, Jiwen; Ashraf, Muhammad; Xu, Xiaoming

• Influence of In Vitro Release Methods on Assessment of Tobramycin Ophthalmic Ointments

  Patere, Shilpa; Newman, Bryan; Wang, Yan; Choi, Stephanie; Mekjaruskul, Catheleeya; Jay, Michael; Lu, Xiuling

• Scanning Analysis of Sequential Semisolvent Vapor Impact To Study Naltrexone Release from Poly(lactide-co-glycolide) Microparticles

  Garner, John; Skidmore, Sarah; Hadar, Justin; Park, Haesun; Park, Kinam; Otte, Andrew; Jhon, Young Kuk; Xu, Xiaoming; Qin, Bin; Wang, Yan