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)

• Modeling of CNS Delivery for Nose-to-Brain Targeted Drug Products

  Walenga, Ross

• Abbreviated New Drug Application (ANDA) and Pre-ANDA Experience with Orally Inhaled Drug Product (OIDP) Modeling

  Walenga, Ross

• ANDA and Pre-ANDA Experience with OIDP Modeling

  Walenga, Ross

• In Silico and Experimental Methods to Support Generic Nasal Drug Product (NDP) Development

  Walenga, Ross

• Bridging the Gap Between Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation

  Walenga, Ross

• Role of Computational Fluid Dynamics and Physiologically-Based Pharmacokinetic Modeling in Development of Orally Inhaled and Nasal Drug Products

  Walenga, Ross

• Credibility Establishment for Computational Fluid Dynamics Models of Complex Generic Drug Delivery

  Walenga, Ross

• Computational Fluid Dynamics Modeling of Nasally Administered Drug Products in Regulatory Science Research at the U.S. Food and Drug Administration

  Walenga, Ross

• Role of Computational Fluid Dynamics and Physiologically-Based Pharmacokinetic Modeling in Development of Orally Inhaled and Nasal Drug Products

  Walenga, Ross

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

  Walenga, Ross