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)

• Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model

  Zhao, Liang

• Research Overview and Regulatory Experience on Mechanistic Modeling for Generic Dermatological Drug Products

  Alam, Khondoker

• Q1 and Q2 Recommendations: Sucralfate Oral Suspension

  Al Ghabeish, Manar

• Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products, Part 2

  Arora, Sumit

• Impact of Fractional Solubility on Drug Permeation from Topical Formulations

  Ajjarapu, Srinivas

• Influence of Metamorphosis on the Performance of Topical Formulations

  Ajjarapu, Srinivas

• Physiologically Based Pharmacokinetic (PBPK) Oral Absorption Model to Predict Mucosal Permeability of Oral Cavity Drug Products

  Kalra, Priyata; Le Merdy, Maxime; Lukacova, V; Dwivedi, Pankaj; Alam, K; Tsakalozou, Eleftheria; Pauletti, G; Zhou, Haiying

• In Silico Predictive Modeling of the Pharmacokinetic (PK) Profiles of Nasal Sprays in Adults and Children

  Kaviratna, Anubhav; Mohan, Abhinav R; Newman, Bryan; Walenga, Ross; Dutta, Rabijit; Kolanjiyil, Arun; Longest, P Worth; Golshahi, Laleh

• Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants

  Costello, Mark; Liu, Joseph; Kuehster, Louise; Wang, Yan; Qin, Bin; Lynd, Nathaniel A; Zhang, Feng

• Understanding the Relationship Between In Vitro Nasal Spray Characteristics and Intranasal Deposition in the Adult and Pediatric Populations

  Hejazi, Mohammed; Khadka, Prakash; Esmaeili, AR; Schuman, Theodore; Kaviratna, Anubhav; Newman, Bryan; Walenga, Ross; Hindle, Michael; Longest, Worth; Golshahi, Laleh