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(66)
• Posters(11)
• Presentations(47)
• Papers(8)

• Perspectives on Current Quality and Bioequivalence Challenges for Complex Products

  O’Reilly Beringhs, Andre; Delvadia, Renishkumar

• ICH M13 Guideline Series

  Zhang, Lei

• Mastering Controlled Correspondences: What, When, and How

  Wang, Yan

• The Development and Framework of MMF as a Regulatory Initiative

  Zhao, Liang

• The Development and Framework of MMF as a Regulatory Initiative

  Zhao, Liang

• When Modeling & Simulation Meets AI

  Zhao, Liang

• Applying Modeling & Simulation to Support Drug Lifecycle Management

  Zhao, Liang

• Model-Integrated Evidence (MIE) Industry Meeting Pilot Between FDA and Generic Drug Applicants

  Zhao, Liang

• Introduction: Statistical Approaches to establishing Bioequivalence

  Zhao, Liang

• M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms ��� Implementing the Final Guidance

  Zhang, Lei; Tampal, Nilufer; Kim, Myong Jin