GDUFA Research Outcomes

Topical Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.

• All(415)
• Posters(179)
• Presentations(216)
• Papers(20)

• Translating Scientific Advances to Regulatory Methods Assessment of Cutaneous Pharmacokinetics

  Ghosh, Priyanka

• Characterization Based Approaches for Establishing Bioequivalence Locally Acting Drug Products Applied to the Skin

  Ghosh, Priyanka; Luke, Markham

• Product Development Considerations and Bioequivalence Strategies for Generic Topical Products

  Ghosh, Priyanka

• Overview FDA’s Generic Drug Research Topical Dermatological Drug Products

  Ghosh, Priyanka

• Identification of Research Needs During Product Development Prior to ANDA Submission

  Ghosh, Priyanka

• Towards Building a Dermal Model for BE Assessment: The Role of Drug Product Characterization and Performance Data

  Ghosh, Priyanka

• Advanced Technologies and Evolving Paradigms: Characterization of Topical Semisolid Dosage Forms

  Ghosh, Priyanka

• Theoretical Principles and Best Practices In Vitro Permeation Testing (IVPT)

  Ghosh, Priyanka

• IVPT Data Challenges and Statistical Analysis

  Ghosh, Priyanka

• Evaluation of Cutaneous Pharmacokinetics The Past, The Present, and The Future

  Ghosh, Priyanka