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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Utilizing Physiologically Based Pharmacokinetic Modeling and Virtual Simulation for Simvastatin Tablets to Evaluate the Sensitivity of Using Parent vs Metabolite as Analyte on Bioequivalence Assessment
Cheng, Yi-Hsien; Wu, Fang; Yoon, Miyoung; Zhao, Liang; Fang, Lanyan
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An Ingestible Device for Automated Sampling and Location Tracing in Gastrointestinal Tract
Li, T; Felton, J; Lewis, J; Cheng, Q; Meredith, R; Lu, HT; Benken, A; Dutta, PP; Liao, J; Zhao, XD; Matvekas, A; Baker, J; Hasler, WL; Babiskin, A; Walenga, R; Fang, L; Lionberger, R; Pal, MP; Sun, D; and Gianchandani, YB
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Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions
Cheng, YH; Pal, A; Moody, R; Heimbach, T; Lukacova, V; Patel, N; Rullo, G; Xu, Y; Ahmed, T; Kerwash, E; Fang, L; Wu, F
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In Vitro Oral Cavity Permeability Assessment to Enable Simulation of Drug Absorption
Dwivedi, Pankaj; Kalra, Priyata; Zhou, Haiying; Alam, Khondoker; Tsakalozou, Eleftheria; Al-Ghabeish, Manar; Kelchen, Megan; Pauletti, Giovanni
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Food Effect and Formulation: How Soluble Fillers Affect the Disintegration and Dissolution of Tablets in Viscous Simulated Fed State Media
Umer, MF; Stahl, V; Al-Gousous, J; Nawroth, T; Sun, WJ; Wu, F; Jiang, W; Gao, Z; Langguth, P
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Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use
Fang, Lanyan; Tsakalozou, Eleftheria; Wu, Fang; Ritterbeck, Daniel; Zhao, Liang; Zhang, Lei; Lionberger, Robert
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Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report
Tannergren, Christer; Arora, Sumit; Babiskin, Andrew; Borges, Luiza; Chatterjee, Parnali; Cheng, Yi-Hsien; Dallmann, Andre’; Govada, Anitha; Heimbach, Tycho; Hingle, Martin; Kollipara, Sivacharan; Kotsagiorgis, Evangelos; Lindhal, Anders; Mackie, Claire; Malamatari, Maria; Mitra, Amitava; Moody, Rebecca; Pepin, Xavier; Polli, James E; Raines, Kimberly; Rullo, Gregory; Sanghavi, Maitri; Savkur, Rajesh; Singh, Rajendra; Sjogren, Erik; Suarez-Sharp, Sandra; Thomas, Sherin; Veerasingham, Shereeni; Wei, Kevin; Wu, Fang; Xu, Yunming; Yoon, Miyoung; Rege, Bhagwant
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PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations
Wu, Fang; Tsakalozou, Eleftheria; Burckart, Gilbert J; Zakelj, Rebeka; Gaohua, Lu; Sagawa, Kazuko; Lukacova, Viera; Vaithiyalingam, Siva; Fan, Jianghong; Fotaki, Nicoletta; Patel, Nikunjkumar; Fang, Lanyan
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Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13A with the Advancements of Physiologically Based Pharmacokinetic Modeling: a Workshop Summary Report
Pal, Arindom; Alam, Khondoker; Stier, Ethan M; Heimbach, T; Cristofoletti, R; Al-Gousous, Jozef; Langguth, Peter; Zakelj, Rebeka; Ahmed, Tausif; Almeida, Susana; Fan, Jianghong; Kolhatkar, Vidula; Paixao, Paulo; Rayeni, Mohan Krishna; Zhang, Lei K; Wu, Fang
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A Physiologically Based Biopharmaceutics Modeling (PBBM) Framework for Characterizing Formulation-Dependent Food Effects: Paving the Road towards Fed Virtual BE Studies for Itraconazole Amorphous Solid Dispersions
Rudolph, Niklas; Charbe, Nitin; Plano, David; Al Shoyaib, Abdullah; Pal, Arindom; Boyce, Heather; Zhao, Liang; Wu, Fang; Polli, James; Dressman, Jennifer; Cristofoletti, Rodrigo