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)

• Opening Remarks to the FDA and the Center for Research on Complex Generics (CRCG) Workshop: Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches

  Corrigan-Curay, Jacqueline

• Predicting Dermal Absorption in Diseased or Damaged Skin Using PBPK Modelling

  Clarke, James; Roberts, Michael

• Utilizing Mechanistic Dermal Absorption Models to Assess Virtual BE

  Clarke, James

• Formulation Drug Product Quality Attributes Additions in Dermal PBPK Model

  Clarke, James

• Assessment of Effects of Selective Airway Luminal Expansion on Inhaled Particle Deposition in Severe Asthmatic Human Lungs – A Numerical Study

  Choi, Jiwoong; Choi, Sanghun; Hoffman, Eric; O’Shaughenessy, Patrick; Castro, Mario; Delvadia, Renishkumar; Walenga, Ross; Babiskin, Andrew; Lin, Ching-Long

• Characteristics of Inhaled Particle Deposition in the Lungs of Imaging-based Asthma Clusters: a Numerical Study

  Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; O’shaughnessy, P; Wenzel, S; Castro, M; Fain, S; Jarjour, N; Schielbler, M; Denlinger, L; Lin, C

• Cluster-guided Imaging-based CFD Analysis of Airflow and Particle Deposition in Asthmatic Human Lungs

  Choi, J; Leblanc, L; Choi, S; Haghighi, B; Hoffman, E; Lin, C

• A Population PK Based Model-Integrated BE Platform

  Chen, X; Nyberg, H; Assawasuwannakit, P; Ryeznik, Y; Karlsson, M

• Current Scientific Considerations in Modeling for In Vitro BE of Topically Administered Ophthalmics

  Chandran, Sajeev

• Approaches in Establishing BE Safe Space for Oral Solid Dosage Form

  Chakraborty, Sumon