GDUFA Research Outcomes

Other Generics Resaerch

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

• 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

• Pioneering Modeling Methodologies in Generic Drug Development

  Zhao, Liang

• Application of Quantitative Methods and Modeling to Generic Drug Development

  Zhao, Liang

• GDUFA III Teleconferences and Meetings

  Zhang, Lei

• Complex Drug Products and Potential Challenges to Generic Drug Development

  Zhang, Lei

• Opening Remarks

  Zhang, Lei

• Role of Regulatory Science in Generic Drug Development and Application Assessment

  Zhang, Lei; Lee, Sau

• Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development

  Zhang, Lei