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)

• Estimating Size-specific Numbers of Active Pharmaceutical Ingredient Particles in the Regional Deposition of a Nasal Spray

  Kimbell, Julia; Schroeter, Jeffry; Tian, Geng; Walenga, Ross; Babiskin, Andrew; Delvadia, Renishkumar

• Effect of Actuation Force on Simulated Regional Nasal Spray Deposition in a Healthy Nasal Cavity

  Kimbell, Julia; Schroeter, Jeffry; Sheth, Poonam; Tian, Geng; Delvadia, Renishkumar; Saluja, Bhawana; Walenga, Ross

• Simulating Nasal Spray Deposition: Effects of Spray Nozzle Presence in the Nasal Vestibule

  Kimbell, Julia; Stricklin, Daniela; Schroeter, Jeffry

• A Multiscale Modeling Approach To Optimize Pulmonary Drug Delivery

  Kannan, Ravi; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• A Bayesian Population Compartmental Absorption and Transit Modeling Approach to Support Generic Drug Development and Regulation – Application to Bupropion

  Hsieh, Nan Hung; Bois, Frederic; Tsakalozou, Eleftheria; Yoon, Miyoung; Reisfeld, Brad; Chiu, Weihsheh

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

  Hsieh, Nanhung; Reisfeld, Brad; mChiu, Weihsueh

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

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