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)

• Evaluation of Level A In Vitro In Vivo Correlations (IVIVC) for Nicotine and Fentanyl Transdermal Delivery Systems (TDS) with Transient Heat Exposure by Using Multiple Approaches

  Shin, Soo Hyeon

• In Vitro and In Vivo Evaluation of Three Fentanyl Transdermal Delivery Systems In Conjunction With Transient Heat Exposure

  Shin, Soo Hyeon

• New developments in the Assessment of Cutaneous Bioavailability and Bioequivalence of Topical Dermatological Drug Products Using Dermal Microdialysis

  Senemar, Sharareh

• Exploring the Relationship between Suspension and Solution MDI Formulation Variables and Predicted Lung Deposition

  Schoroeter, Jeffry (should be Schroeter)

• A CFD-PBPK Approach to Simulate Deposition, Absorption, and Bioavailability of Intranasal Corticosteroids

  Schoroeter, Jeffry (should be Schroeter)

• Local and Systemic Absorption Predictions of Nasal Inhaled Corticosteroids: A Combined Approach

  Schoroeter, Jeffry (should be Schroeter)

• Prediction II: Computational Fluid Dynamics, as part of a workshop titled Bridging the Gap from Science to Clinical Efficacy: Imaging, Modelling, and Physiology of Aerosols and the Lung

  Schoroeter, Jeffry (should be Schroeter)

• Varying Particle Size And Excipient Levels For Three Mdis: Effects On In-Vitro Performance

  Sandell, Dennis

• In vitro and in vivo characterization of ophthalmic suspensions

  Sailor, M

• Discriminative in Vitro Dissolution Testing for Orally Inhaled Drug Products

  Sakagami, Masahiro