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)

• Pathways for Receiving FDA’s Feedback on Formulations

  Phung, Truog-Vinh

• Challenges and Opportunities in the Development of IVRT and IVIVC of Complex Injectable Formulations

  Pepin, Xavier

• Nonregulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use

  Peck, Carl

• Common Deficiencies and Considerations on Setting Appropriate Specifications for Intravaginal Rings

  Paudel, Kalpana

• Mechanistic Modelling of Dermal Drug Absorption Using Simcyp Mpml Mechderma Model Rationale behind Model Development, Its Shape And Performance

  Patel, Nikunj; Cristea, Sinziana; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian

• Diffusion Cell Apparatus: Considerations for Design and Use I

  Patel, Ashvin

• IVPT Method Development, Validation, and Transfer

  Patel, Hiren

• PBPK Modeling of Dermally Applied Drug Products to Support Clinical Development and Regulatory Assessment

  Patel, Nikunkkumar

• Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

  Patel, Nikunkkumar

• Pbpk Modelling of Dermal Drug Absorption and Population Variability Simcyp Mpml Mechderma Model

  Patel, Nikunj; Martins, Frederico; Cristea, Sinziana; Salem, Farzaneh; Abduljalil, Khaled; Jamei, Masoud; Polak, Sebastian