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)

• Impact of Orally Inhaled and Nasal Drug Product PBPK Models on Product Development and Regulatory Decision Making

  Walenga, Ross

• In Silico QbD for Dermal Topical Formulations via TCAT Model Simulations

  Spires, Jessica

• STATISTICAL EXPERIENCE AND CHALLENGES IN ASSESSING SIMILARITY OF DISSOLUTION PROFILES, PARTICAL SIZE DISTRIBUTIONS AND API SAMENESS

  Tsong, Yi

• Are We Ready to Apply Oral PBPK Modeling for BE Determination?

  Tsang, Yu Chung

• Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation ��� A Case Study with Dapsone Topical Gel

  Tsakalozou, Eleftheria

• Applications of Mechanistic Modeling and Simulation Tools on the Performance of Locally Acting Complex Drug Products

  Tsakalozou, Eleftheria

• Considerations and Potential Regulatory Applications for a Model Master File

  Tsakalozou, Eleftheria

• Mechanistic Modeling and Simulation Approaches for Performance Prediction of Locally Acting Complex Drug Products

  Tsakalozou, Eleftheria

• Physiologically-Based Pharmacokinetic Modeling to support Bioequivalence and Drug Approval

  Tsakalozou, Eleftheria

• Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance

  Tsakalozou, Eleftheria