GDUFA Research Outcomes
OA Models
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.
-
Utilizing Physiologically Based Pharmacokinetic Modeling and Virtual Simulation to Evaluate the Sensitivity of Using Parent vs Metabolite as Analytes on Bioequivalence Assessment for Simvastatin
Cheng, Yi Hsien; Wu, Fang; Yoon, Miyoung; Fang, Lanyan(Lucy); Zhao, Liang
-
Physiologically-based Absorption Modeling and Simulation for Assessing Bioequivalence in Elderly, Children and Gastrointestinal Diseases States
Babiskin, Andrew; Lionberger, Robert; Bai, Jane; Zhang, Xinyuan; Burckart, Gilbert; Mulberg, Andrew; Sinha, Vikram; Uno, Tsukasa
-
Assessing the Impact of Excipient and Food Intake on Bioequivalence Using PBPK and Virtual Bioequivalence Trial: A Case Example with Acyclovir Immediate Release Tablets
Al Shoyaib, Abdullah; Fang, Lanyan; Zhao, Liang; Wu, Fang