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)

• 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

• Asymmetric Flow Field Flow Fractionation for the Characterization of Globule Size Distribution in Complex Formulations: A Cyclosporine Ophthalmic Emulsion Case

  Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Krishnaiah, Yellela; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance

  Hu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Kozak, Darby; Shen, Meiyu; Weng, Yuting; Zhao, Liang; Lionberger, Robert

• Computational Modeling of Drug Transport across the In Vitro Cornea

  Pak, Joseph; Chen, Zhijian; Sun, Kay; Przekwas, Andrzej; Walenga, Ross; Fan, Jianghong