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 Vitro Bioequivalence Testing of Nasal Sprays Using Multiple Anatomically-Correct Nasal Airway Models

  Golshahi, Laleh; Manniello, Michele; Hosseini, Sana; Alfaifi, Ali; Schuman, Theodore; Hindle, Michael; Longest, Worth; Sandell, Dennis

• Modeling Temperature-Dependent Dermal Absorption and Clearance for Transdermal and Topical Drug Applications

  Lacount, Terri; Zhang, Qian; Hao, Jinsong; Ghosh, Priyanka; Raney, Sam; Talattof, Arjang; Kasting, Gerald; Li, Kevin

• Estimating Aerosol Size Distributions and Doses Entering the Trachea

  Byron, Peter; Wei, Xiangyin; Bormann, Katharina

• A Physiologically-Based Pharmacokinetic Model to Estimate Absorption and Bioavailability of Corticosteroid Nasal Sprays

  Schroeter, JD; Rose, M; Kimbell, JS; Chopski, S; Walenga, R

• A Systematic Approach in the Development of the Morphologically-Directed Raman Spectroscopy Methodology for Characterizing Nasal Suspension Drug Products

  Farias, Goncalo; Shur, Jagdeep; Price, Robert; Bielski, Elizabeth; Newman, Bryan

• Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time

  Walenga, Ross; Babiskin, Andrew; Zhang, Xinyuan; Absar, Mohammad; Zhao, Liang; Lionberger, Robert

• Absorption and Clearance of Pharmaceutical Aerosols in the Human Nose: Development of a CFD Model

  Longest, Worth

• Effects of Dose Loading Conditions and Device Geometry on the Transport and a Aerosolization in Dry Powder Inhalers: A Simulation Study

  Sulaiman, Mostafa; Liu, Xiaoyu; Sundaresan, Sankaran

• Comparing MDI and DPI Aerosol Deposition Using In Vitro Experiments and a New Stochastic Individual Path (SIP) Model of the Conducting Airways

  Longest, Worth; Tian, Geng; Walenga, Ross; Hindle, Michael

• International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

  Lu, Dongmei; Lee, Sau; Lionberger, Robert; Choi, Stephanie; Adams, Wallace; Caramenico, Hoainhon; Chowdhury, Badrul; Conner, Dale; Katial, Rohit; Limb, Susam; Peters, John; Yu, Lawrence; Seymour, Sally; Li, Bing