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.

• All(113)
• Posters(9)
• Presentations(91)
• 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

• FDA Product-Specific Guidance Program Overview

  Bengston, Karen

• 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

• Pioneering Modeling Methodologies in Generic Drug Development

  Zhao, Liang

• Application of Quantitative Methods and Modeling to Generic Drug Development

  Zhao, Liang