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)

• Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products

  Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products

  Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Novel Method for Bench-top 19F NMR in Measuring API Phase Partition for Oil-in-Water Emulsion Drug Products

  Wang, Xinyi; Patil, Sharadrao; Chen, Kang

• Modeling Approach for Assessing the Impact of Physicochemical Properties on Bioequivalence of Cyclosporine Ophthalmic Emulsion

  Walenga, Ross; Babiskin, Andrew; Absar, Mohammad; Zhang, Xinyuan; Zhao, Liang; Lionberger, Robert

• Effect of Physicochemical Properties of Q1/Q2 Ophthalmic Suspensions on Ocular Bioavailability and Bioequivalence

  Vooturi, S; Bourne, D; Panda, J; Choi, S; Kim, H; Yandrapu, S; Kompella, U

• Impact of Manufacturing Processes on Critical Quality Attributes of Brinzolamide Ophthalmic Suspensions

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

• Pitfalls and Challenges of Analyzing Particle Size Distribution in Ophthalmic Suspensions Using Laser Diffraction

  Vo, Anh; Feng, Xin; Kozak, Darby; Choi, Stephanie; Xu, Xiaoming

• Development of an Ocular Physiologically-Based Pharmacokinetic Model to Describe the Impact of Formulation Attributes on the Disposition of an Antibiotic Applied on the Rabbit Eye

  Tsakalozou, Eleftheria; LeMerdy, Maxime; Babiskin, Andrew; Zhao, Liang

• 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