GDUFA Research Outcomes

Complex Routes of Delivery

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 enhance the efficiency of bioequivalence (BE) approaches for complex routes of delivery, such as locally-acting gastrointestinal (GI), buccal, sublingual, inhalation, nasal, ophthalmic, otic, and topical dermatological, vaginal and rectal products. The advancement of research in this area focuses on understanding of how ingredients and other aspects of a formulation influence drug absorption via complex routes of delivery, building in vivo predictive models and identifying corresponding failure modes for BE, to support the development of efficient BE approaches for these products.

Outcomes including scientific publications, presentations, and posters arising from GDUFA-funded research in this priority area are available in this section.

• All(1036)
• Posters(360)
• Presentations(435)
• Papers(241)

• In-Vivo Flux: A Breakthrough in IVIVC of Topical Dermatological Formulations

  Kuzma, Benjamin

• Estimation of in-Vivo Percutaneous Permeation (Flux) and Cumulative Amount Input of Metronidazole Formulations in Mini-Pigs�۪ Dermis

  Kuzma, Benjamin

• A Semi-physiological Approach for Evaluating the Sensitivity of Pharmacokinetics to Detect Differences in Regional Lung Deposition of Orally-inhaled Drug Products (OIDPs)

  Kurumaddali, Abhinav

• Generic Drug User Fee Amendments (GDUFA) Research and the Product-Specific Guidance (PSG) Program for Complex Products: Challenges and Notable Advances

  Kozak, Darby

• Considerations for Post-Approval Changes to Complex Generic Drug Products

  Kozak, Darby

• A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges

  Kozak, Darby

• Approaches Using Proactive Research in Support of Product-Specific Guidance (PSG) Development

  Xu, Xiaoming

• Formulation Considerations for In Vitro Characterization Based Approaches of Locally Acting Complex Generic Drug Products

  Kozak, Darby

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby

• Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods

  Kozak, Darby