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)

• Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Jogarao

• Commentary on ���Exploration of Suitable Pharmacodynamic Parameters for Acarbose Bioequivalence Evaluation: a Series of Clinical Trials with Branded Acarbose�۪ by Jie Huang et al

  Zhang, Peijue; Lee, Jieon; Feng, Kairui; Babiskin, Andrew; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang

• Evaluation of Model-Integrated Evidence Approaches for Pharmacokinetic Bioequivalence Studies using Model Averaging Methods

  Nyberg, Henrik B; Chen, Xiaomei; Donnelly, Mark; Fang, Lanyan; Zhao, Liang; Karlsson, Mats O; Hooker, Andrew C

• Model-Based Bioequivalence Approach for Sparse Pharmacokinetic Bioequivalence Studies: Model Selection or Model Averaging?

  Philipp, Morgane; Tessier, Adrien; Donnelly, Mark; Fang, Lanyan; Feng, Kairui; Zhao, Liang; Grosser, Stella; Sun, Guoying; Sun, Wei-Jhe; Mentre, France; Bertrand, J

• Development and Comparison of Model-Integrated Evidence Approaches for Bioequivalence Studies with Pharmacokinetic End Points

  Chen, Xiaomei; Nyberg, Henrik B; Donnelly, Mark; Zhao, Liang; Fang, Lanyan; Karlsson, Mats O; Hooker, Andrew C

• Exploration of the Potential Impact of Batch-to-Batch Variability on the Establishment of Pharmacokinetic Bioequivalence for Inhalation Powder Drug Products

  Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Jogarao

• Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products

  Walenga, Ross; Babiskin, Andrew; Bhoopathy, Sid; Clark, James F; De Backer, Jan; Ducharme, Murray; Kelly, Marc; Le Merdy, Maxime; Yoon, Miyoung; Roy, Partha

• Predicting Human Dermal Drug Concentrations using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

  Van Osdol, William; Novakovic, Jasmina; Le Merdy, Maxime; Tsakalozou, Eleftheria; Ghosh, Priyanka; Spires, Jessica; Lukacova, Viera

• Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

  Tsakalozou, Eleftheria; Mohamed, Mohamed-Eslam F; Polak, Sebastian; Heimbach, Tycho

• RPEM: Randomized Monte Carlo Parametric Expectation Maximization Algorithm

  Chen, Rong; Schumitzky, Alan; Kryshchenko, Alona; Nieforth, Keith; Tomashevskiy, Michael; Hu, Shuhua; Garreau, Romain; Otalvaro, Julian; Yamada, Walter; Neely, Michael N