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)

• 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

• In Vitro Physicochemical Characterization and Dissolution of Brinzolamide Ophthalmic Suspensions with Similar Composition

  Vo, Anh; Feng, Xin; Patel, Deval; Mohammad, Adil; Patel, Mehulkumar; Zheng, Jiwen; Kozak, Darby; Choi, Stephanie; Ashraf, Muhammad; Xu, Xiaoming

• Cyclosporine Release and Distribution in Ophthalmic Emulsions Determined by Pulsatile Microdialysis

  Bellantone, Robert; Shah, Kosha; Patel, Piyush; Kaplan, Marissa; Xu, Xiaoming; Li, Vincent; Newman, Bryan; Kaisar, Md Abul

• Adaptive Perfusion: An In Vitro Release Test (IVRT) for Complex Drug Products

  Patel, Deval; Zhang, Ying; Dong, Yixuan; Qu, Haiou; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Biopharmaceutics of Topical Ophthalmic Suspensions: Importance of Viscosity and Particle Size in Ocular Absorption of Indomethacin

  Toropainen, Elisa; Fraser-Miller, Sara; Novakovic, Dunja; Del Amo, Eva; Vellonen, Kati-Sisko; Ruponen, Marika; Viitala, Tapani; Korhonen, Ossi; Auriola, Seppo; Hellinen, Laura; Reinisalo, Mika; Tengvall, Unni; Choi, Stephanie; Absar, Mohammad; Strachan, Clare; Urtti, Arto

• In Vitro and Ex Vivo Correlation of Drug Release from Ophthalmic Ointments

  Bao, Quanying; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane

• Regulating Generic Ophthalmologic Drug Bioequivalence—Envisioning Accessibility for Patients

  Kozak, Darby

• Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension

  Le Merdy, Maxime; Fan, Jianghong; Bolger, Michael; Lukacova, Viera; Spires, Jessica; Tsakalozou, Eleftheria; Patel, Vikram; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Narayanasamy, Suresh; Rouse, Rodney; Matta, Murali; Babiskin, Andrew; Kozak, Darby

• Recent Advances in Topical Ocular Drug Delivery

  Palakurthi, Srinath

• Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations

  Lemerdy, Maxime; Spires, Jessica; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Xu, Xiaoming; Zhao, Liang; Bolger, Michael