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)

• Topical Nano and Microemulsions for Skin Delivery

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

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

  Polli, James E.

• 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

• Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

  Donnelly, Mark; Tsakalozou, Eleftheria; Sharan, Satish; Straubinger, Thomas; Bies, Robert; Zhao, Liang

• Applying a Global Sensitivity Analysis Workflow to Improve the Computational Efficiencies in Physiologically-Based Pharmacokinetic Modeling

  Hsieh, Nanhuang; Reisfeld, Brad; Bois, Frederic; Chiu, Weihsueh

• Leveraging In Vitro Bioequivalence Tests for Locally-Acting Suspension Nasal Sprays with Three Anatomically-Correct Replicas of Human Nasal Airways Representing Intersubject Variability

  Golshahi, L; Alfaifi, A; Hosseini, S; Esmaeili, AR; Hindle, M; Longest, P; Schuman, TA