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)

• In Vitro Evaluation of Regional Drug Deposition in Nasal Airways of Children Using Realistic Anatomical Replicas

  Esmaeili, A; Hosseini, S; Wilkins, J; Alfaifi, A; Dhapare, S; Walenga, R; Newman, B; Schuman, T; Edwards, D; Longest, W; Hindle, M; Golshahi, L

• Physiologically-Based Pharmacokinetic Pediatric Skin Model

  Edginton, Andrea; Yun, Esther; Hamadeh, Abdullah

• Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation

  Dytta, R; Kolanjiyil, A; Golshahi, L; Longest, W

• Model-Integrated BE Approaches for Long-Acting Injectables

  Ducharme, Murray

• Model Integrated Equivalence for BE Assessment of Long Acting Injectables: In Silico Continuation to Steady State

  Ducharme, Murray

• Development Strategies for Generic Topical Products with Formulation Differences to Reference Listed Drug

  Dubey, Vaibhav

• Regulatory Challenges with Pharmacokinetic (PK) Bioequivalence (BE) Studies for Drugs Containing Endogenous Compounds

  Donnelly, Mark

• Discussion with EMA PKWG and CVSWP: Levothyroxine NTI Classification and BE Approach

  Donnelly, Michael; Fang, Lanyan(Lucy)

• Demonstrating Bioequivalence with Inhalation Spray Drug Products

  Dhapare, Sneha

• Pharmacometric Approach To Define Narrow Therapeutic Index (NTI) Drugs & Evaluate Bioequivalence (BE) Criteria for NTI Drugs

  Dahmane, Elyes; Gobburu, Joga; Ivaturi, Vijay