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)

• Developing Regulatory Standards for Characterizing Critical Quality Attributes and Performance Attributes for Topical Semisolid Dosage Forms

  Raney, Sam

• Approaches for Evaluation of Formulation Differences on Performance of Topical Products

  Ramezanli, Tannaz

• A Case Study to Evaluate the Performance of Dermal Open Flow Microperfusion and Dermal Microdialysis for Assessing the Cutaneous Pharmacokinetics of Topical Lidocaine and Prilocaine Cream

  Ramezanli, Tannaz

• Translating Science to Regulatory Tools: Novel Approaches for characterizing and Evaluating the Performance of Topical Drug Products

  Ramezanli, Tannaz

• Characterizing In Vivo Cutaneous Pharmacokinetics of Topical Lidocaine Prilocaine Cream Using Dermal Open Flow Microperfusion and Dermal Microdialysis

  Ramezanli, Tannaz

• Novel Approaches for Evaluating Bioavailability and Bioequivalence (BE) of Topical Drug Products

  Ramezanli, Tannaz

• Therapeutic Equivalence of Compositionally Different Topical Products: Correlation of Product Characteristics with Sensorial Attributes

  Ramezanli, Tannaz

• Practical Considerations for IVRT Studies with Topical Drug Products Submitted in ANDAs

  Ramezanli, Tannaz

• Development of Efficient Alternative Bioequivalence Approaches for Topical Dermatological Drug Products

  Ramezanli, Tannaz

• Theoretical Principles and Best Practices In Vitro Release Testing (IVRT)

  Ramezanli, Tannaz