GDUFA Research Outcomes

Ophthalmic-Otic Products

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

• 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

• 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

• 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