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(452)
• Posters(198)
• Presentations(229)
• Papers(25)

• Best Practices & Efficient Strategies for Generic Topical Product Development

  Ramezanli, Tannaz

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

  Ramezanli, Tannaz

• Bioquivalence of Topical Products Scientific Consideration

  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

• 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

• Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

  Patel, Nikunkkumar

• Pbpk Modelling of Dermal Drug Absorption and Population Variability Simcyp Mpml Mechderma Model

  Patel, Nikunj; Martins, Frederico; Cristea, Sinziana; Salem, Farzaneh; Abduljalil, Khaled; Jamei, Masoud; Polak, Sebastian

• Development And Validation Of Dermal Pbpk Model Towards Virtual Bioequivalence Assessment

  Patel, Nikunkkumar