GDUFA Research Outcomes

Ophthalmic-Otic Products

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

• Preclinical Evaluation of Brinzolamide Ophthalmic Suspensions with Variations in Critical Quality Attributes and Considerations for Pharmacokinetic and Pharmacodynamic Study Designs

  O’Reilly Beringhs, Andre; Naageshwaran, Vatsala; Gum, Glenwood; Malla, Spundana; Vo, Anh; Smith, William; Tan, Ming-Lian; Babiskin, Andrew; Wang, Yan; Xu, Xiaoming; Kozak, Darby

• Tear Film Thickness (TFT) is the Most Sensitive Measure to Capture Differences in the Critical Quality Attributes of a Formulation Using Anterior Optical Coherence Tomography (AS-OCT)

  Naageshwaran, Vatsala; Gum, Glenwood; Kumar, Sandeep; Manza, Linda; Lyulkin, Mathew; Cook, Nicholas; Xu, Xiamoning; Patel, Deval; Qu, Haiou; Walenga, Ross; Tan, Ming-Liang; Babiskin, Andrew; Kaisar, Mohmmad Abul; Kozak, Darby

• Impact of Variations in Critical Quality Attributes of Brinzolamide Ophthalmic Suspensions on Preclinical Pharmacokinetics and Pharmacodynamics Following Once Daily Topical Instillations

  O’reilly Beringhs, Andre; Naageshwaran, Vatsala; Gum, Glenwood; Seremak, D; Malla, Spundana; Vo, A; Tan, Ming-Liang; Babiskin, Andrew; Wang, Y; Kozak, Darby

• Measuring Drug Partitioning and Release to Support In Vitro Bioequivalence of Generic Ophthalmic Emulsion Drugs

  Kozak, Darby; Zhu, Dongkai; Zhang, Ying; Dong, Yixuan; Patel, Deval; Xu, Xiamoning

• What do We Know About PLGA Polymers in FDA-approved Drug Products: A Journey of Characterizing PLGA Polymers and Formulations

  Qin, Bin; Wang, Yan; Zhang, Qiangnan; Li, Qi; Kozak, Darby

• Adaptive Perfusion: A Novel In Vitro Release Testing Method for Complex Ophthalmic Drug Products

  Zhu, Dongkai; Zhang, Ying; Deval, Patel; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Impact of Variations in Critical Quality Attributes of Brinzolamide Ophthalmic Suspensions on Preclinical Pharmacokinetics and Pharmacodynamics Following Once Daily Topical Instillations

  O’Reilly Beringhs, Andre; Naageshwaran, Vatsala; Gum, G; Seremak, D; Malla, S; Vo, A; Tan, Ming-Liang; Babiskin, Andrew; Wang, Yan; Kozak, Darby

• AI-Assisted Tool to Improve the Quality and Assessment of PLGA Formulations

  Das, Jayanti; Hasan, Md Easin; Smith, William; Graner, John; Qin, Bin; Wang, Yan; Park, Kinam; Tian, Geng; Xu, Xiaoming

• Automated Adaptive Perfusion: A Novel In Vitro Release Testing System for Complex Drug Products

  Zhu, Dongkai; Zhang, Ying; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Adaptive Perfusion: A Novel In Vitro Drug Release Testing Method for Complex Drug Products

  Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming