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)

• Leveraging Dermal Physiologically-based Pharmacokinetic Modeling and Simulation Approaches for the Approval of a Generic Diclofenac Sodium Topical Gel

  Tsakalozou, Eleftheria

• Scientific and Regulatory Considerations on Dermal PBPK Modeling for Virtual Bioequivalence Assessments and Decision-making

  Tsakalozou, Eleftheria

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 1

  Alam, Khondoker

• Promising Technologies: Continuous Skin Sampling Methods for Cutaneous PK-Based Bioequivalence Assessment

  Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank

• Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART I

  Thomas, Sherin

• In Vitro Evaluation of a Buprenorphine Transdermal Delivery System with Transient Heat Exposure and the Correlation of In Vitro Results with Existing In Vivo Results

  Thomas, Sherin

• GDUFA Research Update on Mechanistic Modeling Approaches for Generic Ophthalmic, Nasal, Implant and Injectable Drug Products

  Tan, Mingliang

• Physiologically-based Pharmacokinetic Modeling to Support Generic Ophthalmic Product Development and Regulatory Decision Making

  Tan, Mingliang

• Assessing Topical Drug Bioavailability in the Skin Using Raman Spectroscopy

  Tabosa, Alice

• Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling

  Tan, Ming-Liang