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)

• Impact of Fatty Acids on In Vitro Performance of Clindamycin Phosphate Vaginal Creams

  Yue, Weizhou; Xie, Lingxiao; Kelchen, Megan; Ghosh, Priyanka; Niu, Mengmeng; Raney, Sam G.; Shen, Jie

• AI-Assisted Tool to Improve the Quality and Assessment of PLGA Formulations

  Das, Jayanti; Hasan, Md Easin; Smith, William; Graner, John; Qin, Bin; Wang, Yan; Park, Kinam; Tian, Geng; Xu, Xiaoming

• Impact of Variations in Critical Quality Attributes of Brinzolamide Ophthalmic Suspensions on Preclinical Pharmacokinetics and Pharmacodynamics Following Once Daily Topical Instillations

  O’Reilly Beringhs, Andre; Naageshwaran, Vatsala; Gum, G; Seremak, D; Malla, S; Vo, A; Tan, Ming-Liang; Babiskin, Andrew; Wang, Yan; Kozak, Darby

• Assessment of Bio(in)Equivalence of Metronidazole Topical Formulations using Stimulated Raman Scattering Microscopy

  Zarmpi, P; Tsikritsis, D; Watson, AC; Vorng, JL; Tyagi, V; Belsey, N; Woodman, TJ; White, KAJ; Ghosh, P; Bunge, AL; Delgado-Charro, MB; Guy, RH

• Current Methods for Assessing Bioequivalence of Drug Products Applied to the Skin ��� a US FDA Perspective

  Kelchen, Megan; Xie, Lingxiao; Luke, Markham; Ghosh, Priyanka

• In vitro-In vivo Comparison of Cooling Sensation in Topical Gel Products

  Phan, Khanh; Liu, David; Panchal, Bhavesh; Namjoshi, Sarika; Ramezanli, Tannaz; Ghosh, Priyanka; Raney, Sam G.; Luke, Markham; Roberts, Michael; Mohammed, Yousuf

• Facilitating Drug Development Through GDUFA Regulatory Science and Research Opportunities for Collaboration with FDA

  Ghosh, Priyanka; Ramezanli, Tannaz; Luke, Markham

• Development of a CFD PK Nasal Spray Model with In Vivo Human Subject Validation

  Dutta, R; Kolanjiyil, AV; Golshahi, L; Longest, W

• Open Flow Microperfusion As A Dermal Pharmacokinetic Approach To Evaluate Topical Bioequivalence

  Bodenlenz, M; Tiffner, K; Raml, R; Tschapeller, B; Augustin, T; Dragatin, C; Birngruber, T; Kainz, S; Schwagerle, G; Korsatko, S; Raney, S; Sinner, F

• Automated Adaptive Perfusion: A Novel In Vitro Release Testing System for Complex Drug Products

  Zhu, Dongkai; Zhang, Ying; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming