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(475)
• Posters(107)
• Presentations(231)
• Papers(137)

• Evaluation of Model-based Bioequivalence Approach for Single Sample Pharmacokinetic Studies

  Tardivon, Coralie; Loingeville, Florence; Donnelly, Mark; Feng, Kairui; Sun, Wanjie; Sun, Guoying; Grosser, Stella; Zhao, Liang; Fang, Lanyan; Mentre, France; Bertrand, Julie

• Establishing Quantitative Relationships Between Changes in Nasal Spray In Vitro Metrics and Drug Delivery to the Posterior Nasal Region

  Kolanjiyil, AV; Walenga, Ross; Babiskin, Andrew; Golshahi, L; Hindle, Michael; Longest, Worth

• Computational Model of In Vivo Corneal Pharmacokinetics and Pharmacodynamics of Topically Administered Ophthalmic Drug Products

  German, Carrie; Chen, Zhijian; Przekwas, Andrzekj; Walenga, Ross; Babiskin, Andrew; Liang, Zhao; Fan, Jianghong; Tan, Ming-Liang

• Prediction of In Vitro Drug Dissolution into Fasted-State Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity

  Polli, James E.

• Topical Nano and Microemulsions for Skin Delivery

  Nastiti, Christofori; Ponto, Thellie; Abd, Eman; Grice, Jeffrey; Benson, Heather; Roberts, Michael

• An Effective PBPK Model Predicting Dissolved Drug Transfer from a Representative Nasal Cavity to the Blood Stream

  Dave, Sujal; Kleinstreuer, Clement; Chari, Sriram

• Effect of Inflow Conditioning for Dry Powder Inhalers

  Singh, Gajendra; Lowe, Albyn; Azeem, Athiya; Cheng, Shaokoon; Chan, Hak-Kim; Walenga, Ross; Kourmatzis, Agisilaos

• Development of a Stochastic Individual Path (SIP) Model for Predicting the Tracheobronchial Deposition of Pharmaceutical Aerosols: Effects of Transient Inhalation and Sampling the Airways

  Tian, Geng; Longest, Worth; Su, Guoguang; Walenga, Ross; Hindle, Michael

• Multi-Phase Multi-Layer Mechanistic Dermal Absorption (MPML MechDermA) Model to Predict Local and Systemic Exposure of Drug Products Applied on Skin

  Patel, N; Clarke, J F; Salem, F; Abdulla, T; Martins, F; Arora, S; Tsakalozou, E; Hodgkinson, A; Arjmandi-Tash, O; Cristea, S; Gosh, P; Alam, K; Raney, Sam G; Jamei, M; Polak, S

• Predicting Systemic and Pulmonary Tissue Barrier Concentration of Orally Inhaled Drug Products

  Singh, Narender; Kannan, Ravi; Arey, Ryan; Walenga, Ross; Babiskin, Andrew; Przekwas, Andrzej