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)

• Mechanistic Modeling to Support Development and Approval of Non-Orally Administered Generic Drug Products

  Walenga, Ross

• Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Simulation with Alternative BE Approaches

  Walenga, Ross

• Leveraging Modeling Approaches to Support Bioequivalence Determination for Generic Orally Inhaled Drug Products in the United States

  Walenga, Ross

• FDA Recommendations for Alternative Bioequivalence Approaches: Design, Validation, and Use Case for In Silico Studies

  Walenga, Ross

• Sensitivity of Charcoal Block PK Metrics to Differences in Regional Deposition for Budesonide and Formoterol Fumarate Dihydrate

  Walenga, Ross; Tsakalozou, Eleftheria; Chopski, Steven; Fang, Lanyan (Lucy); Liang, Zhao

• Modeling and Simulation to Support Development and Approval of Generic Orally Inhaled Drug Products

  Walenga, Ross

• Application and Validation of Mechanistic Modeling for Generic Drug Products at the U.S. Food and Drug Administration (FDA)

  Walenga, Ross; Tan, Ming-Lian; Wu, Fang

• Complex Nasal Suspensions: Utilization of In Silico Studies to Support Development and Approval

  Walenga, Ross

• Utilizing In Vitro and In Silico Methods to Accelerate Product Development for Generic Nasal Drug Products

  Walenga, Ross

• Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products

  Walenga, Ross