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)

• Strategic Development of Generic Long-Acting Injectables: Model-Integrated Evidence Approaches

  Gong, Yuqing

• Alternative Model-Based Data Analysis Approach to Demonstrate Bioequivalence

  Gong, Yuqing

• Drug-Disease Modeling Approach to Describe the Relationship Between Long-Acting Methlyphenidate Exposure and Clinical Response

  Gomeni, Roberto

• Leveraging In Vitro Bioequivalence Tests for Locally-Acting Suspension Nasal Sprays with Three Anatomically-Correct Replicas of Human Nasal Airways Representing Intersubject Variability

  Golshahi, L; Alfaifi, A; Hosseini, S; Esmaeili, A; Hindle, M; Longest, W; Schuman T

• Pathways to Establish Bioequivalence and Facilitate Development of Innovative and Generic Intranasal Drug Delivery Products: In vitro Anatomically Correct Nasal Models

  Golshahi, Laleh

• In Vitro Bioequivalence Testing of Nasal Sprays Using Multiple AnatomicallyCorrect Nasal Airway Models

  Golshahi, L; Manniello, M; Hosseini, S; Alfaifi, A; Schuman, T; Hindle, M; Longest, W; Sandell, D

• Accelerating LAI Generic Development Using Model-Integrated Bioequivalence

  Gobburu, Joga

• General Approach to the Safety Review of Pediatric Excipients

  Ghosh, Amrita

• A Model-Integrated Pathway to Explore Bioequivalence of LAI Products: Studies Using Paliperidone Palmitate

  Gajjar, Parmesh

• Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART II

  Fotaki, Nikoletta