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)

• Applying A Global Sensitivity Analysis Workflow to Improve Computational Efficiencies in Physiologically-Based Pharmacokinetic Model

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

• Pksensi: an R Package to Apply Sensitivity Analysis in Pharmacokinetic Modeling

  Hsieh, Nanhung; Reisfeld, Brad; mChiu, Weihsueh

• Integrating Cellular Disposition Of Doxorubicin Into A Multiscale Physiologically Based Pharmacokinetic Model In Mice And Scale-Up To Humans.

  He, Hua; Wu, Yun; Liu, Can; Cao, Yanguang

• In Vitro Evaluation of Regional Drug Deposition in Nasal Airways of Children Using Realistic Anatomical Replicas

  Esmaeili, A; Hosseini, S; Wilkins, J; Alfaifi, A; Dhapare, S; Walenga, R; Newman, B; Schuman, T; Edwards, D; Longest, W; Hindle, M; Golshahi, L

• Cluster-guided Image Matching Analysis of Multiscale Lung Response to Bronchial Thermoplasty

  Choi, Jiwoong; Choi, Sanghun; Li, Frank; Hoffman, Eric; Castro, Mario; Goss, Charles; Hall, Chase; McEleney, Stephen; Sieren, Jered; Lin, Chinglong

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

  Choi, Jiwoong; LeBlanc, Lawrence; Choi, Sanghun; Haghighi, Babak; Hoffman, Eric; O’Shaughnessy, Patrick; Wenzel, Sally; Castro, Mario; Fain, Sean; Jarjour, Nizar; Schiebler, Mark; Denlinger, Loren; Lin, Chinglong

• 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

• 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