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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Pre-ANDA Meeting or Controlled Correspondence?
Andre, Kris
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Complex Products – GDUFA II Pre-ANDA Program
Andre, Kris
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Using the ePortal for Pre-ANDA Meeting Requests
Andre, Kris
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In Vitro Assessments that Support In Vitro Binding Studies in Demonstrating Bioequivalence of Locally Acting Gastrointestinal Drugs
Al Ghabeish, Manar
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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