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)

• PBPK Modeling for Different Locally-Administered Drug Products

  Jereb, Rebeka

• Establishing Bioequivalence Using Characterization Based Approaches for Topical Products – Challenges & Solutions

  Jani, Romit

• Predictive Performance of PBPK Dose Estimates for Pediatric Trials

  Dallmann, Andre

• Use of PBPK in New Drug Development and Regulatory Review – Clinical Pharmacology Perspective

  Huang, Shiew-Mei

• Challenges in Processing PK Data from ANDA Submissions for BE Assessment and Current Perspectives on Updating the PK Data Standard

  Hu, Meng

• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach

  Hu, Meng

• Model-Integrated Methods and Innovative Study Designs for Generic LAI Product Development and Regulatory Assessment

  Hooker, Andrew

• Development and Comparison of Model-based Bioequivalence Analysis Methods on Sparse Data

  Hooker, Andrew; Nyberg, Henrik; Karlsson, Mats; Chen, Xiaomei

• Model-based Approaches as Guidance to Bioequivalence Decision Making: Design and Analysis Considerations

  Hooker, Andrew

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, Changning