GDUFA Research Outcomes

Ophthalmic-Otic Products

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

• Locally Acting Drug Products: Bioequivalence Challenges and Opportunities

  Choi, Stephanie

• Bioequivalence Requirements for Ophthalmic Products: CMC and Clinical/Pharmacokinetic Considerations

  Choi, Stephanie

• Developing PBPK for Ocular Delivery

  Bolger, Michael

• Equivalence of Complex Products Cyclosporine Ophthalmic Emulsion

  Gong, Xiajing

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

  Costello, Mark; Liu, Joseph; Kuehster, Louise; Wang, Yan; Qin, Bin; Lynd, Nathaniel A; Zhang, Feng

• Preclinical Evaluation of Brinzolamide Ophthalmic Suspensions with Variations in Critical Quality Attributes and Considerations for Pharmacokinetic/Pharmacodynamic Study Designs

  Beringhs, Andre O’reilly; Naageshwaran, Vatsala; Gum, Glenwood; Malla, Spundana; Vo, Anh; Smith, William; Tan, Ming Liang; Babiskin, Andrew; Xu, Xiaoming; Kozak, Darby

• In-Vivo and Biopredictive In-Vitro Dissolution Testing of Dexamethasone Intravitreal Implants in Rabbits

  Johnson, Coleman; Maier, Esther; Bhalla, Aanya; Crowell, Eric; Wang, Yan; Qin, Bin; Zhang, Feng

• Assessing Q1/Q2 Sameness of Polyethylene Glycol Star Polymers as Polymeric Excipients in Dexamethasone Ophthalmic Inserts

  Plavchak, Christine; Smith, William; Vandenberg, Michael; Zaman, Rokon; O’Reilly Beringhs, Andre; Wang, Yan; Xu, Xiaoming

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Ofloxacin Ointment Case Study

  Alqaraghuli, Farah; Le Merdy, Maxime; Tan, Ming-Liang; Lukacova, V

• Exploring the Influence of Drug Substance Solid-State Properties on the In Vitro Drug Release Performance of Dexamethasone Ophthalmic Ointments

  O’Reilly Beringhs, Andre; Mekjarusku, Catheleeya; Qin, Bin; Lu, Xiuling; Wang, Yan