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)

• Development And Validation Of Dermal Pbpk Model Towards Virtual Bioequivalence Assessment

  Patel, Nikunkkumar

• Bioequivalence Considerations for In Vitro Release Test Methods of Ophthalmic Products

  Park, Eunjung

• Verifying the Hygroscopic Particle Growth Model during the Time Relevant to Lung Inspiration

  O’Shaughnessy, Patrick; Altmaier, Ralph; Walenga, Ross; Lin, Ching-Long

• Validation of Computational Predictions of Regional Lung Deposition

  Olsson, Bo

• Influence of Progressive Change in the Degree of Saturation of API on the Performance of Topical Products

  Murthy, S Narasimha

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef

• Modeling for Success: A Case Example for Oseltamivir Phosphate

  Mousa, Youssef

• Development of Methods for Evaluation of Formulation Differences and their Impact on Therapeutic Equivalence: Broadening the Therapeutic Scope

  Mohammed, Yousuf

• Modeling to Support Regulatory Needs of OIDPs

  Mohamed, Raja

• Model-based Statistical Approaches for Pharmacokinetic Bioequivalence Studies with Sparse Sampling and Extension to Two-stage Designs

  Mentre, France; Loingeville, Florence; Rakez, Manel; Nguyen, Thu Thuy; Bertrant, Julie; Mollenhoff, Kathrin; Dette, Holger; Sharan, Satish; Sun, Guoying; Grosser, Stella; Zhao, Liang; Fang, Lanyan