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)

• Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants

  Costello, Mark; Liu, Joseph; Kuehster, Louise; Wang, Yan; Qin, Bin; Lynd, Nathaniel A; Zhang, Feng

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

  Beringhs, Andre O’reilly; Naageshwaran, Vatsala; Gum, Glenwood; Malla, Spundana; Vo, Anh; Smith, William; Tan, Ming Liang; Babiskin, Andrew; Xu, Xiaoming; Kozak, Darby

• In-Vivo and Biopredictive In-Vitro Dissolution Testing of Dexamethasone Intravitreal Implants in Rabbits

  Johnson, Coleman; Maier, Esther; Bhalla, Aanya; Crowell, Eric; Wang, Yan; Qin, Bin; Zhang, Feng

• Assessing Q1/Q2 Sameness of Polyethylene Glycol Star Polymers as Polymeric Excipients in Dexamethasone Ophthalmic Inserts

  Plavchak, Christine; Smith, William; Vandenberg, Michael; Zaman, Rokon; O’Reilly Beringhs, Andre; Wang, Yan; Xu, Xiaoming

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Ofloxacin Ointment Case Study

  Alqaraghuli, Farah; Le Merdy, Maxime; Tan, Ming-Liang; Lukacova, V

• Exploring the Influence of Drug Substance Solid-State Properties on the In Vitro Drug Release Performance of Dexamethasone Ophthalmic Ointments

  O’Reilly Beringhs, Andre; Mekjarusku, Catheleeya; Qin, Bin; Lu, Xiuling; Wang, Yan

• 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