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)

• Bioquivalence of Topical Products Scientific Consideration

  Ramezanli, Tannaz

• CGDP with a Locally-Acting Route of Delivery Including Topical Dermatological Drug Products

  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

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

  Patel, Nikunkkumar

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

  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

• 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

• The Role of Microparticles and Other Excipients in the Complexity of Certain Topical Drug Products

  Niu, Mengmeng

• Effect of excipients on the in vitro permeation of drugs from topical products

  Murthy, Narasimha