GDUFA Research Outcomes

Other Generics Resaerch

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

• 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

• Quantitative Methods and Modeling in Regulatory Science

  Zhao, Liang

• Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why From Generic Drug Perspective

  Zhao, Liang

• Challenges for Industry in Implementing New Computational Methods that Arise from Regulatory Science Initiatives

  Liang, Zhao