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)

• Mathematical Modeling of Skin Absorption and Transport: Foundation Lecture

  Roberts, Michael

• Topical Semisolid Drug Product Critical Quality Attributes (Q3 Characterization) with Relevance to Topical Bioequivalence

  Roberts, Michael

• Statistical Considerations in Assessing BE of IVPT Data

  Rantou, Elena

• Using R for Generic Drug Evaluation and SABE R-package for Assessing Bioequivanlence of Topical Dermatological Products

  Rantou, Elena

• Statistical Issues with Aberrant IVRT/IVPT Data- FDA Perspective

  Rantou, Elena

• Special Cases for the Statistical Evaluation of Bioequivalence: An Example of in-Vitro, Skin Permeation Test Data

  Rantou, Elena

• Assessing Bioequivalence of Locally-Acting Generic Products; Statistical Controversies and Arising Issues

  Rantou, Elena

• Topical Drug Delivery – Scientific and Regulatory Considerations for Generic Drug Products

  Raney, Sam

• Overview of the Topical and Transdermal Stimuli Article “Advances in Product Quality and Performance Tests for Topical and Transdermal Products – View of the USP Expert Panel” – Feedback to USP and Next Steps

  Raney, Sam

• Influence of Physicochemical & Structural Formulation Attributes on Topical Bioavailability

  Raney, Sam G