GDUFA Research Outcomes

Ophthalmic-Otic Products

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

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

• GDUFA Regulatory Science Research on In Vitro Bioequivalence Methods

  Kozak, Darby

• In Vitro Bioequivalence Testing for Topical Ophthalmic Suspension Products

  Kozak, Darby

• Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use

  Jones, A; Chung, HS; Kozak, D

• An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• 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

• Locally Acting Drug Products: Bioequivalence Challenges and Opportunities

  Choi, Stephanie