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.
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Leveraging Dermal Physiologically-based Pharmacokinetic Modeling and Simulation Approaches for the Approval of a Generic Diclofenac Sodium Topical Gel
Tsakalozou, Eleftheria
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Scientific and Regulatory Considerations on Dermal PBPK Modeling for Virtual Bioequivalence Assessments and Decision-making
Tsakalozou, Eleftheria
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Physiologically-based Pharmacokinetic Modeling to Guide Study Design and Product Development for Generic Dermatological Products
Tsakalozou, Eleftheria
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Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 1
Alam, Khondoker
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Physiologically-based Pharmacokinetic Modeling and Simulation Approaches: Best Practices for Regulatory Applications Related to Locally-acting Generic Drugs
Tsakalozou, Eleftheria
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Physiologically-based Pharmacokinetic Modeling for the Development of Dermatological Drug Products and its Regulatory Impact
Tsakalozou, Eleftheria
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Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic dermatological products
Tsakalozou, Eleftheria
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Continuous Skin Sampling Methods for the Assessment of Cutaneous PK-Based Bioequivalence
Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank
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Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART I
Thomas, Sherin
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Recommendation of Partial Area Under the Curve (pAUC) Metrics in Product-Specific Guidance for Long-Acting Injectable (LAI) Drug Products
Thomas, Sherin