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)

• Tissue Specific Pk And Pd Enabled By Open Flow Microperfusion: From Bioequivalence To Mechanism Of Drug Action Poc Studies

  Sinner, Frank

• A Predictive Multiscale Computational Tool for Simulation of Lung Absorption and Pharmacokinetics and Optimization of Pulmonary Drug Delivery

  Singh, Narender

• Effect of Varying Inflow Conditions on Pharmaceutical Powder Dynamics in Inhaler-like Flows

  Singh, Gajendra

• A Multiscale Computational Framework for Inhalation Pharmacology and Drug Development

  Singh, Narender; Kannan, Ravi; Przekwas, Andrzej

• In Vitro Bioequivalence Data for a Topical Product: Chemistry Review Perspective

  Simamora, Pahala

• Alternative In Vitro Bioequivalence Approaches for the Low GWP Propellant Transition

  Silva, Lucas

• Advanced Characterization Approaches to Demonstrate Bioequivalence of Nasal Suspension Drug Products

  Shur, Jag

• The Development of Predictive Dissolution Methods for Orally Inhaled Drug Products

  Shur, Jag

• In Vivo Evaluation of Lidocaine Bioavailability from Two Topical Patch Products by Pharmacokinetic and Skin (Tape) Stripping Analyses

  Shukla, Sagar

• Impact of Operator Variability on the Reproducibility of Tape Stripping Results

  Shukla, Sagar; Thomas, Sherin; Hammell, Dana; Bunge, Annette; Hassan, Hazem; Stinchcomb, Audra