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)

• Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model

  Zhao, Liang

• Formulation Drug Product Quality Attributes Additions in Dermal PBPK Model

  Babiskin, Andrew

• Role of Biopredictive Dissolution and Oral PBPK to Evaluate the Impact of Food on Drug Absorption

  Al-Gousous, Jozef; Langguth, P

• Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges

  Andre, Kris

• Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products

  Alam, Khondoker

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2

  Arora, Sumit

• Excipient Safety Assessment in Generic Drug Formulations: An Overview

  Agarwal, Stuti

• Expectations and Common Deficiencies for IVRT Studies Submitted in ANDAs for Ophthalmic Emulsion Products

  Abuznait, Alaa

• Mechanistic Modeling of Intramuscular Administration of Long-acting Injectable Suspensions Accounting for Fibrosis at the Depot Site

  Silva, Daniela Amaral; Malavia, Nilesh; Burgess, Daine J; Khondoker, Alam; Wang, Yan; Lukacova, Viera

• Physiologically Based Pharmacokinetic (PBPK) Oral Absorption Model to Predict Mucosal Permeability of Oral Cavity Drug Products

  Kalra, Priyata; Le Merdy, Maxime; Lukacova, V; Dwivedi, Pankaj; Alam, K; Tsakalozou, Eleftheria; Pauletti, G; Zhou, Haiying