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)

• Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches: A Workshop Overview

  Babiskin, Andrew; Wu, Fang; Mousa, Youssef; Tan, Ming Liang; Tsakalozou, Eleftheria; Walenga, Ross; Yoon, Miyoung; Raney, Sam G; Polli, James; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, AV; Golshahi, L; Longest, P

• The Influence of Secondary Processing on the Structural Relaxation Dynamics of Fluticasone Propionate

  Depasquale, Roberto; Lee, Sau; Saluja, Bhawana; Shur, Jagdeep; Price, Robert

• ASCPT 2019 Annual Meeting Pre-conference

  Bai, Jane; Musante, Cynthia; Petanceska, Suzana; Zhang, Lei; Zhao, Liang; Zhao, Ping

• Computational Analysis of a 3D Mucociliary Clearance Model Predicting Nasal Drug Uptake

  Chari, Sriram; Sridhar, Karthik; Walenga, Ross; Kleinstreuer, Clement

• Physiologically-based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

  Tsakalozou, Eleftheria; Babiskin, Andrew; Zhao, Liang

• Scientific and Regulatory Activities Initiated by the U.S. Food and Drug Administration to Foster Approvals of Generic Dry Powder Inhalers: Bioequivalence Perspective

  Newman, Bryan; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan; Feibus, Karen; Kaviratna, Anubhav; Li, Bing V; Luke, Markham; Ma, Tian; Walenga, Ross; Wang, Zhong; Zhao, Liang; El-Gendy, Nashwa; Bertha, Craig; El-Shafy, Mohammed; Gaglani, Dhaval

• A Multiscale Physiologically-Based Pharmacokinetic Model for Doxorubicin to Explore its Mechanisms of Cytotoxicity and Cardiotoxicity in Human Physiological Contexts

  He, Hua; Liu, Can; Wu, Yun; Zhang, Xinyuan; Fan, Jianghong; Cao, Yanguang

• Mathematical Modeling of the Heterogeneous Distributions of Nanomedicines in Solid Tumors

  He, Hua; Liu, Can; Liu, Yuhui; Liu, Xiaoquan; Wu, Yun; Fan, Jianghong; Zhao, Liang; Cao, Yanguang

• Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time

  Walenga, Ross; Babiskin, Andrew; Zhang, Xinyuan; Absar, Mohammad; Zhao, Liang; Lionberger, Robert