GDUFA Research Outcomes

Quantitative Methods & Models

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 facilitate the utility of model-integrated evidence (MIE) to support demonstrations of bioequivalence (BE). The advancement of research in this area focuses on developing tools and advancing approaches to integrate complementary in silico (modeling), in vivo, and in vitro evidence in ways that collectively mitigate the risk of failure modes for BE and support a framework for virtual BE studies. For example, while it may not be feasible to adequately characterize the long-term bioavailability of drugs from LAI products using in vivo or in vitro methods alone, it may be feasible to integrate limited in vivo and in vitro data with PBPK models that generate the remaining evidence needed to support a demonstration of BE. This area includes research on the use of MIE to evaluate failure modes for BE and to optimize the design of BE studies.

Outcomes including scientific publications, presentations, and posters arising from GDUFA-funded research in this priority area are available in this section.

• All(606)
• Posters(148)
• Presentations(304)
• Papers(154)

• Comparing MDI and DPI Aerosol Deposition Using In Vitro Experiments and a New Stochastic Individual Path (SIP) Model of the Conducting Airways

  Longest, Worth; Tian, Geng; Walenga, Ross; Hindle, Michael

• Diffusion Modelling of Percutaneous Absorption Kinetics. Predicting Urinary Excretion from In Vitro Skin Permeation Tests (IVPT) for an Infinite Dose

  Liu, Xin; Yousef, Shereen; Anissimov, Yuri; Van Der Hoek, John; Hoek, John; Tsakalozou, Eleftheria; Ni, Zhanglin; Grice, Jeffrey; Roberts, Michael

• Validating CFD Predictions of Pharmaceutical Aerosol Deposition with In Vivo Data

  Tian, Geng; Hindle, Michael; Lee, Sau; Longest, Worth

• Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera

• In Vivo Predictive Dissolution: Transport Analysis of the CO2 , Bicarbonate in Vivo Buffer System

  Krieg, Brian; Taghavi, Seyed; Amidon, Gordon; Amidon, Gregory

• Recent Developments in the Computational Simulation of Dry Powder Inhalers

  Capecelatro, Jesse; Longest, Worth; Boerman, Connor; Sulaiman, Mostafa; Sundaresan, Sankaran

• Deposition of Particles in the Alveolar Airways: Inhalation and Breath-Hold with Pharmaceutical Aerosols

  Longest, Worth

• Applications of Adaptive Designs in Generic Drug Development

  Lee, Jieon; Feng, Kairui; Xu, Mingjiang; Gong, Xiajing; Sun, Wanjie; Kim, Jessica; Zhang, Zhen; Wang, Meng; Fang, Lanyan; Zhao, Liang

• Well-Tempered MCMC Simulations for Population Pharmacokinetic Models

  Bois, Frederic; Hsieh, Nan-Hung; Gao, Wang; Chiu, Weihsueh; Reisfeld, Brad

• Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products

  Zhao, Liang; Seo, Paul; Lionberger, Robert