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)

• Differences in Particle Deposition between Members of Imaging-Based Asthma Clusters

  Choi, Jiwoong; Leblanc, Lawrence; Choi, Sanghun; Haghighi, Babak; Hoffman, Eric; O’shaughnessy, Patrick; Wenzel, Sally; Castro, Mario; Fain, Sean; Jarjour, Nizar; Schielbler, Mark; Denlinger, Loren; Delvadia, Renishkumar; Walenga, Ross; Babiskin, Andrew; Lin, Ching-Long

• The Role of Tight Junctions in Skin Barrier Function and Dermal Absorption

  Bäsler, Katja; Bergmann, Sophia; Heisig, Michael; Naegel, Arne; Zorn Kruppa, Michaela; Brandner, Johanna

• Modified Regulatory Pathways to Approve Generic Drugs in the Us and a Systematic Review of Their Outcomes

  Kesselheim, Aaron; Polinski, Jennifer; Fulchino, Lisa; Isaman, Danielle; Gagne, Joshua

• Assessment of Vehicle Volatility and Deposition Layer Thickness in Skin Penetration Models

  Hamadeh, Abdullah; Troutman, John; Edginton, Andrea

• Physiologically Based Pharmacokinetic Modeling of Nanoparticles

  Yuan, Dongfen; He, Hua; Wu, Yun; Fan, Jianghong; Cao, Yanguang

• Hypertension Pharmacogenomics: in Search of Personalized Treatment Approaches

  Johnson, Julie

• Development of a Stochastic Individual Path (SIP) Model for Predicting the Deposition of Pharmaceutical Aerosols: Effects of Turbulence, Polydisperse Aerosol Size, and Evaluation of Multiple Lung Lobes

  Longest, Worth; Tian, Geng; Delvadia, Renishkumar; Hindle, Michael

• Mathematical Modelling of the Viable Epidermis: Impact of the Cell Shape and Vertical Arrangement

  Wittum, Rebecca; Naegel, Arne; Heisig, Michael; Wittum, Gabriel

• Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension

  Le Merdy, Maxime; Fan, Jianghong; Bolger, Michael; Lukacova, Viera; Spires, Jessica; Tsakalozou, Eleftheria; Patel, Vikram; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Narayanasamy, Suresh; Rouse, Rodney; Matta, Murali; Babiskin, Andrew; Kozak, Darby

• Topical Drug Delivery: History, Percutaneous Absorption, and Product Development

  Roberts, Michael S; Cheruvu, Hanumanth; Mangion, Sean; Alinaghi, Azadeh; Benson, Heather A E; Mohammed, Yousuf; Holmes, Amy; Hoes, John Van Der; Pastore, Michael; Grice, Jeffery E