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(162)
• Posters(65)
• Presentations(34)
• Papers(63)

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

  Costello, Mark; Liu, Joseph; Kuehster, Louise; Wang, Yan; Qin, Bin; Xu, Xiaoming; Li, Qi; Smith, William C; Lynd, Nathaniel A; Zhang, Feng

• Reverse Engineering the Ozurdex Dexamethasone Intravitreal Implant

  Costello, Mark; Liu, J; Wang, Yan; Bin, Qin; Xu, Xiaoming; Li, Qi; Lynd, Nathaniel A; Zhang, F

• Drug Release Mechanisms of High-Drug-Load, Melt-Extruded Dexamethasone Intravitreal Implants

  Costello, Mark; Liu, Joseph; Chen, Beibei; Wang, Yan; Qin, Bin; Xu, Xiaoming; Li, Qi; Lynd, Nathaniel A; Zhang, Feng

• Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions

  Belenos, Avery; Wood, Erin; Hu, Meng; Kozak, Darby; Xu, Xiaoming; Fisher, Adam

• Mechanistic Modeling of Ophthalmic, Nasal, Injectable, and Implant Generic Drug Products: a Workshop Summary Report.

  Tan, Ming-Liang; Chandran, Sajeev; Jereb, Rebeka; Alam, Khondoker; Bies, Robert; Kozak, Darby; Walenga, Ross; Le Merdy, Maxime; Babiskin, Andrew

• Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera

• Impact of Apparatus and Adapter on In vitro Drug Release of Ophthalmic Semisolid Drug Products

  Mekjaruskul, Catheleeya; O’Reilly Beringhs, Andre; Qin, Bin; Wang, Yan; Chowdhury, Pallabita; Lu, Xiuling

• Topical Pharmacokinetics of Brinzolamide Suspensions in Rabbits and Variability Analysis for Sample Size and Design Considerations

  Naageshwaran, Vatsala; Bigonne, Helene; Gum, Glenwood; Malla, Spundana; Sol, Charity Del; Bon, Charles; Xu, Xiamoning; Vo, Anh; Smith, William; Beringhs, Andre O’reilly; Kozak, Darby; Tan, Mingliang; Babiskin, Andrew; Babiskin, Andrew; Urtti, Arto; Amo, Eva Del; Ranta, Veli Pekka

• Computational Model of In Vivo Corneal Pharmacokinetics and Pharmacodynamics of Topically Administered Ophthalmic Drug Products

  German, Carrie; Chen, Zhijian; Przekwas, Andrzekj; Walenga, Ross; Babiskin, Andrew; Liang, Zhao; Fan, Jianghong; Tan, Ming-Liang

• Topical Pharmacokinetics of Dexamethasone Suspensions in the Rabbit Eye: Bioavailability Comparison

  Naageshwaran, Vatsala; Ranta, Veli Pekka; Toropainen, Elisa; Tuomainen, Marjo; Gum, Glenwood; Xie, Enli; Bhoopathy, Siddhartha; Urtti, Arto; Del Amo, Eva