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)

• A Predictive Multiscale Computational Tool for Simulation of Lung Absorption and Pharmacokinetics and Optimization of Pulmonary Drug Delivery

  Singh, Narender

• Effect of Varying Inflow Conditions on Pharmaceutical Powder Dynamics in Inhaler-like Flows

  Singh, Gajendra

• A Multiscale Computational Framework for Inhalation Pharmacology and Drug Development

  Singh, Narender; Kannan, Ravi; Przekwas, Andrzej

• Development of PBPK Model for Predicting Food Impact on BE Assessment

  Shoyaib, Abdullah

• Application of Quantitative Clinical Pharmacology (QCP) in Development of Long Acting Injectable Products

  Sharan, Satish

• Prediction of Human Pharmacokinetics Utilizing In Vitro Chewing Method and Physiologically Based Pharmacokinetic (PBPK) Analyses for Abuse-Deterrent Hydrocodone Bitartrate Extended Release Tablets

  Sharan, Satish

• Application of Modeling and Simulation in Establishing Appropriate Bioequivalence Limits for Complex Formulations

  Sharan, Satish

• Evaluation Of Residual Levonorgestrel As Potential Bioequivalence Metric For A Long Acting Intrauterine System Using Quantitative Modeling And Simulation Approach

  Sharan, Satish

• The In Vitro Release Test (IVRT): Historical Perspective, Current Context, and Future Directions

  Shah, Vinod

• A CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Intranasal Corticosteroids

  Schoroeter, Jeffry (should be Schroeter)