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(162)
• Posters(65)
• Presentations(34)
• Papers(63)

• Comparison of In-Vitro and In-Vivo Drug Release of Dexamethasone/PLGA Intravitreal Implants Using Two In-Vitro Release Methods and a Rabbit Model

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

• Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Tan, MingLiang; Lukacova, Viera

• Impact of Polymer Source Variations on Hydrogel Structure and Product Performance in Dexamethasone-Loaded Ophthalmic Inserts

  VandenBerg, Michael; Zaman, Rokon Uz; Plavchak, Christine; Smith, William; Nejad, Hossein Birjandi; O; Reilly Beringhs, Andre; Wang, Yan; Xu, Xiaoming

• Quasi-3D Mechanistic Model for Predicting Eye Drop Distribution in the Human Tear Film

  Garimella, Harsha; Norris, Carly; German, Carrie; Przekwas, Andrzej; Walenga, Ross; Babiskin, Andrew; Tan, Ming-Liang

• Characterization of the Repeat Unit Sequence of Poly(lactide-co-glycolide)

  Kuehster, Louis; Bingham, Michael; Dai, Jingyi; Jhon, Young Kuk; Wang, Yan; Qin, Bin; Smith, William C; Xu, Xiaoming; Zhang, Feng; and Lynd, Nathaniel A

• Impact of Mechanistic Modeling and Simulation Methodologies on Product Specific Guidance Development for Non-Orally Administered Drug Products

  Chopski, Steven; Walenga, Ross; Tan, Ming-Liang; Alam, Khondoker; Babiskin, Andrew; Fang, Lanyan; Tsakalozou, Eleftheria

• Understanding the Impact of Accelerated Release Testing Conditions on Physicochemical Properties and Drug Release Mechanisms from Etonogestrel Implants based on Ethylene Vinyl Acetate

  Ren, Angela; Zhong, Ziyue; Magaw, Maggie; Wang, Yan; Qin, Bin; Smith, William; Xu, Xiaoming; Listro, Tony; Zhang, Feng

• Investigation of the Thermal Stability and Hydrolytic Degradation Kinetics of Poly(lactide-co-glycolide) Melts

  Chen, Bebei; Costello, Mark A; Kuehster, Louise; Lynd, Nathaniel A; Qin, Bin; Wang, Yan; Zhang, Feng

• Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products

  Walenga, Ross; Alam, Khondoker; Clarke, James F.; De Backer, J.; Friden, Markus; Hamadeh, Abdullah; Mowli, Jay; Sonti, Sujatha; Spires, Jessica; Tan, Ming-Liang; Musuamba, Flora T; Tsakalozou, Eleftheria

• Impact of FDA Regulatory Research on the Landscape of Ophthalmology Drugs

  O’Reilly Beringhs, Andre