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)

• Demonstrating Dermatological Bioequivalence Beyond the in vivo Clinical Endpoint Bioequivalence Study

  Peters, John

• Mechanistic Modelling of Dermal Drug Absorption Using Simcyp Mpml Mechderma Model Rationale behind Model Development, Its Shape And Performance

  Patel, Nikunj; Cristea, Sinziana; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian

• Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

  Patel, Nikunkkumar

• Pbpk Modelling of Dermal Drug Absorption and Population Variability Simcyp Mpml Mechderma Model

  Patel, Nikunj; Martins, Frederico; Cristea, Sinziana; Salem, Farzaneh; Abduljalil, Khaled; Jamei, Masoud; Polak, Sebastian

• Development And Validation Of Dermal Pbpk Model Towards Virtual Bioequivalence Assessment

  Patel, Nikunkkumar

• Verifying the Hygroscopic Particle Growth Model during the Time Relevant to Lung Inspiration

  O’Shaughnessy, Patrick; Altmaier, Ralph; Walenga, Ross; Lin, Ching-Long

• The Role of Microparticles and Other Excipients in the Complexity of Certain Topical Drug Products

  Niu, Mengmeng

• Day 2 Overview

  Newman, Bryan

• FDA Perspective on Scientific and Regulatory Considerations for MDIs Transitioning to a Low Global Warming Potential Propellant

  Newman, Bryan; Luke, Markham

• Challenges & Considerations for the Transition to Low Global Warming Potential (LGWP) Propellants with Metered Dose Inhalers

  Newman, Bryan