GDUFA Research Outcomes

PBPK Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.

• All(360)
• Posters(77)
• Presentations(193)
• Papers(90)

• 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

• IVPT Method Development, Validation, and Transfer

  Patel, Hiren

• Diffusion Cell Apparatus: Considerations for Design and Use I

  Patel, Ashvin

• Bioequivalence Considerations for In Vitro Release Test Methods of Ophthalmic Products

  Park, Eunjung

• Verifying the Hygroscopic Particle Growth Model during the Time Relevant to Lung Inspiration

  O’Shaughnessy, Patrick; Altmaier, Ralph; Walenga, Ross; Lin, Ching-Long

• Validation of Computational Predictions of Regional Lung Deposition

  Olsson, Bo

• Influence of Progressive Change in the Degree of Saturation of API on the Performance of Topical Products

  Murthy, S Narasimha