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)

• Regulatory Utility of Physiologically Based Pharmacokinetic Modeling to Support Alternative Bioequivalence Approaches and Risk Assessment: A Workshop Summary Report

  Wu, F; Mousa, Y; Raines, K; Bode, C; Tsang, YC; Cristofoletti, R; Zhang, H; Heimbach, T; Fang, L; Kesisoglou, F; Mitra, A; Polli, J; Kim, MJ; Fan, J; Zolnik, BS; Sun, D; Zhang, Y; Zhao, L

• Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera

• Mechanistic Modeling of Ophthalmic, Nasal, Injectable, and Implant Generic Drug Products: a Workshop Summary Report.

  Tan, Ming-Liang; Chandran, Sajeev; Jereb, Rebeka; Alam, Khondoker; Bies, Robert; Kozak, Darby; Walenga, Ross; Le Merdy, Maxime; Babiskin, Andrew

• The Role of Capsule Aperture Size on the Dispersion of Carrier-based Formulation at Different Air Flowrates

  Tang, Patricia; Kakhi, Maziar; Albariqi, Ahmed; Behara, Srinivas; Walenga, Ross; Yang, Runyu; Chan, Hak-Kim

• Increasing Impact of Quantitative Methods and Modeling in Establishment of Bioequivalence and Characterization of Drug Delivery

  Yoon, Miyoung; Babiskin, Andrew; Hu, Meng; Wu, Fang; Raney, Sam G.; Fang, Lanyan; Zhao, Liang

• 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