GDUFA Research Outcomes

Other Generics Resaerch

• All(111)
• Posters(8)
• Presentations(90)
• Papers(13)

• Using the ePortal for Pre-ANDA Meeting Requests

  Andre, Kris

• Pre-ANDA Program

  Arora, Sumit

• In Vitro Assessments that Support In Vitro Binding Studies in Demonstrating Bioequivalence of Locally Acting Gastrointestinal Drugs

  Al Ghabeish, Manar

• 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

• Bioequivalence Approaches for Generic Drug Product Development and Approval in the United States

  Zhang, Yi

• 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

• 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

• Scientific and Regulatory Considerations for the Approval of the First Generic Glucagon

  Pang, Eric; Chong, William; Luke, Markham

• 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

• 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