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(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• Pathways for Receiving FDA’s Feedback on Formulations

  Phung, Truog-Vinh

• Challenges and Opportunities in the Development of IVRT and IVIVC of Complex Injectable Formulations

  Pepin, Xavier

• Common Deficiencies and Considerations on Setting Appropriate Specifications for Intravaginal Rings

  Paudel, Kalpana

• Nonregulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use

  Peck, Carl

• 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

• Diffusion Cell Apparatus: Considerations for Design and Use I

  Patel, Ashvin

• IVPT Method Development, Validation, and Transfer

  Patel, Hiren

• PBPK Modeling of Dermally Applied Drug Products to Support Clinical Development and Regulatory 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

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

  Patel, Nikunkkumar