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.
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Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
Jones, A; Chung, HS; Kozak, D
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Bioequivalence Evaluation of Narrow Therapeutic Index Drugs – Rationales for the Current Regulatory Approach by U.S. FDA
Jiang, Wenlei
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U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products
Jiang, Wenlei
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Global Bioequivalence Requirements for Orally Inhaled Drug Products (OIDPs)
Jiang, Wenlei
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Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives
Jiang, Wenlei
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Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices
Jiang, Wenlei
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In Vivo Relevance of Dissolution
Jiang, Wenlei
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Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment
Jiang, Wenlei
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An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Xiaohui
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Session 2: Novel Analytical Tools for Characterization of Nasal Suspensions
Jiang, Xiaohui