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)

• Comparing Device User Interfaces and Seeking Advice in the Pre-ANDA Period

  Hartka, Kathryn

• Alternative Model-Based Data Analysis Approach to Demonstrate Bioequivalence

  Gong, Yuqing

• GDUFA Research and Regulatory Initiatives for Complex Ophthalmic Products

  Choi, Stephanie

• Impact of Excipient Grade (Q1/Q2) on the Bioequivalence of Generic Drug Products

  Choi, Stephanie

• An Update on FDA�۪s Research Program for Ophthalmic Generic Products

  Choi, Stephanie

• 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