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)

• Theoretical Principles and Best Practices In Vitro Release Testing (IVRT)

  Ramezanli, Tannaz

• IVRT Method Development, Validation, and Transfer Theoretical Principles and Practical Challenges

  Ramezanli, Tannaz

• In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches

  Ramezanli, Tannaz

• Best Practices & Efficient Strategies for Generic Topical Product Development

  Ramezanli, Tannaz

• How to Structure Efficient Development Programs for Generic Topical Drug Products

  Ramezanli, Tannaz

• Topical Dermatological Drug Products Complex Generic Drug Products (CGDPs) with a locally-acting route of delivery

  Ramezanli, Tannaz; Simamora, Pahala; Babiskin, Andrew; Luke, Markham

• Bioquivalence of Topical Products Scientific Consideration

  Ramezanli, Tannaz

• PBPK Modeling of Transdermal Selegiline Disposition Discrepancy in Special Populations

  Puttrevu, Santosh Kumar

• Demonstrating Dermatological Bioequivalence Beyond the in vivo Clinical Endpoint Bioequivalence Study

  Peters, John

• Mechanistic Modelling of Dermal Drug Absorption Using Simcyp Mpml Mechderma Model Rationale behind Model Development, Its Shape And Performance

  Patel, Nikunj; Cristea, Sinziana; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian