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.
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In Vitro-In Vivo Relationship Development for Oxybutynin Chloride Extended-Release Tablets to Assess Bioequivalence
Tsakalozou, Eleftheria; Sun, Dajun; Wen, H; Zhang, Xinyuan
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Exploring the Relationship of Drug BCS Classification, Food-Effect, and Gastric pH-Mediated Drug Interactions
Owens, Katie; Argon, Sophie; Yu, Jingliang; Ragueneau-Majlessi, Isabelle; Yang, Xinning; Wu, Fang; Lee, Sue Chih; Sun, Wei Jhe; Ramamoorthy, Anuradha; Zhang, Lei
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Baseline Correction in Bioequivalence Studies for Drug Products Containing an Endogenous Compound
Lim, Hye Lim; Sun, Wei Jhe; Kim, Myong Jin; Lee, Sue Chih
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Evaluation of U.S. FDA Approved Generic Oral Solution Products
Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei
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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
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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
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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