GDUFA Research Outcomes

Ophthalmic-Otic Products

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

• Physical Formulation Features and Ocular Absorption from Topical Suspensions: Toward Mechanistic Understanding

  Toropainen, Elisa; Novakovic, Dunja; Fraser, Sara; Tuomainen, Marjo; Hagstrm, Marja; Amo, Eva del; Vellonen, Kati-Sisko; Peltoniemi, Jonne; Tengvall, Unni; Pelkonen, Laura; Reinisalo, Mika; Ruponen, Marika; Auriola, Seppo; Viitala, Tapani; Absar, Mohammad

• Impact of Particle Flocculation on Dissolution and Implications on Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Impact of Particle Flocculation on Determination of Bioequivalence and Clinical Performance of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming

• Interplay Between Particle Flocculation and Dissolution Leading to Variation in Bioavailability and Clinical Performance of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming

• Influence of polymeric excipients on the precision of particle size distribution measurements of suspensions using laser diffraction

  Smith, William; Vo, Anh; Bae, Jungeun; Wang, Yan; Qin, Bin; Xu, Xiaoming

• Influence of polymeric excipients on the precision of particle size distribution measurements of suspensions using laser diffraction

  Smith, William; Vo, Anh; Bae, Jungeun; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming

• Asymmetical-flow Field Fractionation to Assess the Impact of Manufacturing Process Variables on the Globule Size of Distribution of Cyclosporine Emulsions

  Qu, Haiou; Patel, Deval; Kozak, Darby; Walenga, Ross; Choi, Stephanie; Ashraf, Muhammad; Faustino, Patrick; Cruz, Celia; Xu, Xiaoming

• Determination of Globule Size Distribution of Cyclosporine Ophthalmic Emulsions using Asymmetric Flow Field Flow Fractionation

  Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Yellela, Krishnaiah; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Asymmetric Flow Field Flow Fractionation as an Analytical Tool for the Size Based Separation and Characterization of Complex Ophthalmic Emulsions

  Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Yellela, Krishnaiah; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study

  Qaraghuli, Farah Al; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera; Lemerdy, Maxime