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(57)
• Posters(10)
• Presentations(44)
• Papers(3)

• 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

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

  Zhao, Liang

• Applying Modeling & Simulation to Support Drug Lifecycle Management

  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

• ICH M13A: First ICH Guideline for Bioequivalence

  Zhang, Lei K

• Introduction & Overview: Current Regulatory Horizon of Narrow Therapeutic Index Drugs & ICH Guideline Development for Bioequivalence Assessment

  Zhang, Lei

• Opening Remarks – Global Bioequivalence Harmonization: Enhancing Access to Affordable Medicines

  Zhang, Lei