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(374)
• Posters(145)
• Presentations(185)
• Papers(44)

• SRS Pharmacokinetic Tomography

  Evans, Conor

• Multiphoton Chemical Imaging to Assess Dermal Pharmacokinetics and Pharmacodynamics

  Evans, Conor

• Imaging and Quantifying Topical Drug Uptake in Human Tissue

  Evans, Conor

• The Pursuit of Alternative Methodologies for Demonstrating Bioequivalence for Generic Topical Dermatologic Drug Products

  Wilkin, Jonathan

• Translating Scientific Advances to Regulatory Methods Assessment of Cutaneous Pharmacokinetics

  Ghosh, Priyanka

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

  Ghosh, Priyanka

• In Silico QbD for Dermal Topical Formulations via TCAT Model Simulations

  Spires, Jessica

• 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

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 1

  Alam, Khondoker