GDUFA Research Outcomes

Other Generics Resaerch

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

• Innovation for Generic Drugs: Science and Research under the Generic Drug User Fee Amendments of 2012

  Lionberger, Robert

• Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

  Pepin, Xavier; Parrott, Neil; Dressman, Jennifer; Delvadia, Poonam; Mitra, Amitava; Zhang, Xinyuan; Babiskin, Andrew; Kolhatkar, Vidula; Suarez Sharp, Sandra

• Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

  Madabushi, Rajanikanth; Seo, Paul; Zhao, Liang; Tegenge, Million; Zhu, Hao

• Potential Types of Model Master Files

  Zhao, Liang

• Leveraging Model-Integrated Evidence for Generic Drug Development and Approval

  Zhao, Liang

• Applications and Advance in Using Modeling and Simulation (M&S) to Support Drug Product Life Cycle Management

  Zhao, Liang

• Risk Assessment and Management for Formulation Change Using Model Integrated Approach

  Zhao, Liang

• Overview of GDUFA II-funded Modeling and Simulation Grants/Contracts

  Zhao, Liang

• Impact of Modeling and Simulation on Drug Product Life Cycle Management

  Zhao, Liang

• Computational Pharmaceutics: Scientific Gaps and Forthcoming Research to Modernize Regulatory Science

  Zhao, Liang