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)

• Model-Integrated Bioequivalence Establishment: Long-Acting Injectable Drug Products

  Yoon, Miyoung

• Model-Integrated Evidence for BE Assessment of Complex Generic Drugs

  Yoon, Miyoung

• IVRT Studies During Topical Product Development: Lifecycle Management for SUPAC-SS and Generics

  Yen, Cristina

• IVPT Studies with Sunscreen Products: Experimental Parameters

  Yang, Yang

• Physiologically Based Pharmacokinetic Modeling for BCS IV Drugs and Case Examples

  Wu, Fang

• Totality of Evidence Including PBPK Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets (Part II)

  Wu, Fang

• Physiologically Based Pharmacokinetic Absorption Modeling to Support BCS-Based Waiver of In Vivo Bioequivalence Studies

  Wu, Fang

• Regulatory Perspective of Model Master Files Utilities for Oral Drug Products

  Wu, Fang

• Using Physiologically Based Pharmacokinetic Absorption Modeling for Bioequivalence Evaluation in Adult and Pediatric Populations

  Wu, Fang

• PBPK Modeling for Setting PSD Specifications

  Wu, Fang