GDUFA Research Outcomes

Quantitative Methods & Models

The Generic Drug User Fee Amendments (GDUFA) science and research program facilitates patient access to high-quality generic drugs by advancing research in areas where generic product development has been limited or prevented due to knowledge gaps about the kind of evidence needed to demonstrate that a generic product is the same as its brand name reference listed drug product. Leaders and experts across the generic industry collaborate to establish GDUFA research priorities for the most pressing scientific challenges they face with generic product development. Scientists and clinicians from industry, academia, and the U.S. Food and Drug Administration (FDA) strategically design research in these areas so that the outcomes help to build scientific bridges across the knowledge gaps, thereby facilitating pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop.

A major GDUFA science and research priority is to facilitate the utility of model-integrated evidence (MIE) to support demonstrations of bioequivalence (BE). The advancement of research in this area focuses on developing tools and advancing approaches to integrate complementary in silico (modeling), in vivo, and in vitro evidence in ways that collectively mitigate the risk of failure modes for BE and support a framework for virtual BE studies. For example, while it may not be feasible to adequately characterize the long-term bioavailability of drugs from LAI products using in vivo or in vitro methods alone, it may be feasible to integrate limited in vivo and in vitro data with PBPK models that generate the remaining evidence needed to support a demonstration of BE. This area includes research on the use of MIE to evaluate failure modes for BE and to optimize the design of BE studies.

Outcomes including scientific publications, presentations, and posters arising from GDUFA-funded research in this priority area are available in this section.

• All(606)
• Posters(148)
• Presentations(304)
• Papers(154)

• Application of Quantitative Clinical Pharmacology in the Development of Long-Acting Injectable (LAI) Drug Products

  Zhao, Liang

• Regulatory Perspective: What Can Be a Model Master File and How to Share It?

  Zhao, Liang

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• Symposium 18: Partial Area Under the Curve Analysis in Generic & New Drug Development

  Gallicano, Keith

• Quantitative Methods and Modeling to Support GDUFA Regulatory Science Research Program

  Zhao, Liang

• Regulatory Challenges and Opportunities for Model-based Approaches for Patient Pharmacokinetic (PK) Studies with Sparse Sampling Design

  Zhao, Liang

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang

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

  Zhao, Liang

• General Overview: The Use of Quantitative Methods and Modeling to Facilitate Generic Drug Development and Regulatory Assessment

  Zhao, Liang

• Use of Modeling and Simulation to Support New BE Approaches

  Zhao, Liang