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)

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

  Patel, Nikunkkumar

• 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

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef

• Modeling for Success: A Case Example for Oseltamivir Phosphate

  Mousa, Youssef

• Modeling to Support Regulatory Needs of OIDPs

  Mohamed, Raja

• Development of Methods for Evaluation of Formulation Differences and their Impact on Therapeutic Equivalence: Broadening the Therapeutic Scope

  Mohammed, Yousuf

• Model-based Statistical Approaches for Pharmacokinetic Bioequivalence Studies with Sparse Sampling and Extension to Two-stage Designs

  Mentre, France; Loingeville, Florence; Rakez, Manel; Nguyen, Thu Thuy; Bertrant, Julie; Mollenhoff, Kathrin; Dette, Holger; Sharan, Satish; Sun, Guoying; Grosser, Stella; Zhao, Liang; Fang, Lanyan