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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Identify Biopredictive Dissolution for Predicting In Vivo Performance of a BCS II Drug Product Under Fed Conditions
Du, Ping; Fang, Lanyan; Zhao, Liang; Wu, Fang
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PBPK Modeling to Predict the Effect of Gastric pH on Bioequivalence of Dabigatran Etexilate Capsules
Pal, Arindom; Mousa, Youssef; Fang, Lanyan; Zhao, Liang; Wu, Fang
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Formulation Effects of Marketed Oral Cavity Products on In Vitro Buccal Permeability
Dwivedi, Pankaj; Alam, Khondoker; Tsakalozou, Eleftheria; Al Ghabeish, Manar; Pauletti, Giovanni
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PBPK Modeling to Predict the Effect of Gastric pH on Bioequivalence of Dabigatran Etexilate Capsules
Pal, Arindom; Mousa, Youssef; Fang, Lanyan; Zhao, Liang; Wu, Fang
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Mechanistic Model of In Vitro Intraoral Absorption of Buprenorphine for the Buccal and Gingival Mucosa
Kalra, Priyata; Lukacova, Viera; Dwivedi, Pankaj; Alam, Khondoker; Tsakalozou, E; Pauletti, Giovanni; Zhou, Haiying
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Developing an R Shiny App for Dissolution Profile Similarity Analysis
Gao, Huamin; Thomas, Sherin; Wu, Fang
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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