GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
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Patterns of Bioequivalence Recommendations and Trends of Abbreviated New Drug Approval over Time
Wittayanukorn, S; Babiskin, A; Dutcher, S; Pu, X; Hu, M; Zhao, L; Lionberger, R
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Bioequivalence Approaches for Generic Drug Product Development and Approval in the United States
Zhang, Yi
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What Factors may Impact the Likelihood of First Abbreviated New Drug Application (ANDA) Submission for a Feference Product?
Wittayanukorn, Saranrat; Rosenberg, Matthew; Schick, Andreas; Hu, Meng; Wang, Zhong; Babiskin, Andrew; Zhao, Liang
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Evaluation Of Residual Levonorgestrel As Potential Bioequivalence Metric For A Long Acting Intrauterine System Using Quantitative Modeling And Simulation Approach
Sharan, Satish; Choi, Sungwoo; Zhang, Xinyuan; Zou, Yuan; Wang, Yan; Kim, Myongjin; Choi, Stephanie; Makhlouf, Fairouz; Grosser, Stella; Fang, Lanyan; Zhao, Liang
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Scientific and Regulatory Considerations for the Approval of the First Generic Glucagon
Pang, Eric; Chong, William; Luke, Markham
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Utilization of Pharmacogenomic Information in Bioequivalence Studies for Generic Drug Development
Li, Karen; Shon, Jihong; Boyce, Heather; Lee, Sue Chih; Frost, Mitchell; Kim, Myong-Jin
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Utilizing Viscous Media to Assess Food-Induced Viscosity Effects on Immediate Release Tablet Disintegration and Drug Dissolution
Lex, Timothy; Rodriguez, Jason; Zhang, Lei; Jiang, Wenlei; Gao, Zongming
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A Review of Recent Progress in GDUFA Research Program on PLGA-Based Drug Products: Three Case Studies
Jog, Rajan; Qin, Bin; Zou, Yuan; Kozak, Darby; Wang, Yan
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Physiological-based Absorption Modeling and Simulation of Bioequivalence Between Pelleted, Modified-release Capsule Products Differing in the Mechanism of Release From the Rate-controlling Polymer
Zhang, X