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)

• Computational Modeling of Absorption from Complex Topical Formulations

  Spires, Jessica

• Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why

  Smith, William C

• Intravitreal Sustained Release Ganciclovir: An Orphan Generic

  Smith, Thomas

• Use of Skin Pharmacokinetics (PK) & Pharmacodynamics (PD) in Drug Development

  Sinner, Frank

• In-Vivo Skin PK Testing for New and Generic Topical Dermatological Drug Development

  Sinner, Frank

• Clinical Pharmacokinetic Evaluation of Dermal Bioavailability and Bioequivalence

  Sinner, Frank

• In Vivo Dermal Open Flow Microperfusion: A Novel Approach to Evaluating Topical Bioavailability and Bioequivalence

  Sinner, Frank

• Innovative Dermal PK and PD: In Vivo Proof-of-Mechanism to Clinical Dermal Bioequivalence using Open Flow Microperfusion

  Sinner, Frank

• Dermal Open Flow Microperfusion (Dofm) For The Bioequivalence Assessment Of Topical Products Based On Skin Pk

  Sinner, Frank

• Evaluating Topical Bioavailability In Vivo By Dermal Open Flow Microperfusion And Equivalence By Ivrt

  Sinner, Frank