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)

• Industry Perspective: Incorporation of BE Modeling and LAI Development Challenges

  Fitzgerald, Michael

• ANDA Challenges Related to Vasoconstrictor Studies

  Feng, Kairui

• Model-based Bridging to Establish Bioequivalence With a Discontinued Reference Listed Product

  Feng, Kairui

• Application of Quantitative Modeling and Simulations to Bioequivalence Determination for Long-Acting Injectables ��� Sharing Research Progress and Regulatory Experience

  Feng, Kairui

• Applications and Lessons Learned for Conducting Adaptive Designs in Generic Drug Development

  Feng, Kairui

• Regulatory Considerations in Development of Generic Long-Acting Injectable (LAI) Formulations for HIV Treatment and Prevention

  Fang, Lanyan

• Physiologically Based Pharmacokinetic Absorption Modeling to Support Bioequivalence Assessment for BCS Class III Drug Products

  Fang, Lanyan

• Narrow Therapeutic Index Drug Classification: US FDA Current Process

  Fang, Lanyan

• Leveraging Modeling and Simulation to Streamline Generic Drug Development and Assessment

  Fang, Lanyan

• Partial Area Under Curve (pAUC): Product-Specific Guidance Development and Practice for Product Evaluation

  Fang, Lanyan