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)

• 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

• Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

  Mitra, Amitava; Suarez-Sharp, Sandra; Pepin, Xavier; Flanagan, Talia; Zhao, Yang; Kotzagiorgis, Evangelos; Parrott, Neil; Sharan, Satish; Tistaert, Christophe; Heimbach, Tycho; Zolnik, Banu; Sjogren, Erik; Wu, Fang; Anand, Om; Kakar, Shefali; Li, Min; Veerasingham, Shereeni; Kijima, Shinichi; Santos, Gustavo; Ning, Baoming; Raines, Kimberly; Rullo, Greg; Mandula, Haritha; Delvadia, Poonam; Dressman, Jennifer; Dickinson, Paul; Babiskin, Andrew

• Percutaneous absorption of steroids from finite doses: Predicting urinary excretion from in vitro skin permeation testing

  Liu, Xin; Cheruvu, Hanumanth; Anissimov, Yuri; Van Der Hoek, John; Tsakalozou, Eleftheria; Ni, Zhanglin; Ghosh, Priyanka; Grice, Jeffrey; Roberts, Michael

• In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development

  Walenga, Ross; Dhapare, Sneha; Newman, Bryan; Babiskin, Andrew; Zhao, Liang

• Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations

  Lemerdy, Maxime; Spires, Jessica; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Xu, Xiaoming; Zhao, Liang; Bolger, Michael

• Current Inhalers Delivery very Small Doses to the Lower Tracheobronchial Airways: Assessment of Healthy and Constricted Lungs

  Longest, Worth

• Generating Model Integrated Evidence for Generic Drug Development and Assessment

  Zhao, Liang; Kim, Myongjin; Zhang, Lei; Lionberger, Robert

• A Mechanistic Bayesian Inferential Workflow for Estimation of In Vivo Skin Permeation from In Vitro Measurements

  Hamadeh, Abdullah; Troutman, John; Najjar, Abdulkarim; Edginton, Andrea

• A Quasi-3D Compartmental Multi-Scale Approach to Detect and Quantify Diseased Regional Lung Constriction Using Spirometry Data

  Kannan, Ravishekar; Singh, Narender; Przekwas, Andrzej