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)

• Well-Tempered MCMC Simulations for Population Pharmacokinetic Models

  Bois, Frederic; Hsieh, Nan Hung; Gao, Wang; Chiu, Weihsueh; Reisfeld, Brad

• Integrating Drug Product Quality Attributes in a Bottom-Up Physiologically Based Pharmacokinetic (PBPK) Model to Simulate In Vitro Skin Permeation of Acyclovir Commercial Formulations

  Arora, Sumit; Polak, Sebastian; Jamei, Masoud; Tsakalozou, Eleftheria; Ghosh, Priyanka; Alam, Khondoker; Liu, Xin; Namjoshi, Sarika; Grice, Jeffrey; Mohammed, Yousuf; Roberts, Michael

• Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation

  Arora, S; Patel, N; Polak, S; Jamei, M; Tsakalozou, E; Ghosh, P; Alam, K; Liu, X; Namjoshi, S; Grice, J; Mohammed, Y; Roberts, M

• Simulating the Effect of Propylene Glycol on Acyclovir (Zovirax® Cream, 5%) Permeation Across the Skin Using a Physiologically Based Pharmacokinetic (PBPK) Model of In Vitro Flow-through Skin Permeation

  Arora, Sumit; Patel, Nikunjkumar; Polak, Sebastian; Jamei; Roberts, Michael

• In Vitro-In Vivo Relationships (IVIVR) For Transdermal Delivery Of Nicotine From Patches

  Alinaghi, Azadeh; Cheruvu, Hanumanth; Liu, Xin; Anissimov, Yuri; Kuswahyuning, Rina; Ghosh, Priyanka; Grice, Jeffrey; Raney, Sam; Roberts, Michael

• Does Vehicle Evaporation Affect Drug Distribution within Different Phases of Topically Applied Emulsion? A Modeling Case Study with Clindamycin Phosphate Lotion

  Alam, Khondoker; Tsakalozou, Eleftheria; Babiskin, Andrew; Ghosh, Priyanka; Ramezanli, Tannaz; Jiang, Ying; Niu, Mengmeng; Zhao, Liang

• Predicting the Pharmacokinetics of Topically Applied Ketoprofen using Mechanistic Physiologically-based Pharmacokinetics Modelling

  Abdulla, Tariq; Patel, Nikunjumar; Martins, Federico; Salem, Farzaneh; Clarke, James; Jamei, Masoud; Polak, Sebastian

• Quantitative Prediction of Dermal Drug Absorption using MPML-MechDermA model: Relative Effects of Application Site on Rivastigmine Pharmacokinetics from a Transdermal Delivery System

  Abdulla, T; Patel, N; Polak, S; Martins, F; Rostami-Hodjegan, A; Jamei, M

• Relating Regional Variations in Skin Permeability to the Underlying Skin Morphology in Vivo

  Abd, Eman; Mohammed, Yousef; Naegel, Arne; Grice, J; Wittum, Rebecca; Heisig, Michael; Wittum, Gabriel; Maibach, Howard; Roberts, Michael

• Relationships Between in Vivo Skin Permeability and Regional Variations in Morphological and Biophysical Skin Properties

  Abd, E; Mohammed, Y; Naegel, A; Grice, J; Wittum, R; Heisig, M; Wittum, G; Maibach, H; Roberts, M