GDUFA Research Outcomes

QCP Methods

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to quantitative clinical pharmacology assessments of oral absorption to support generic product development and assessment.

• All(138)
• Posters(42)
• Presentations(65)
• Papers(31)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Experience Learned and Perspectives on Using Model Integrated Evidence in the Regulatory Context for Generic Drug Products

  Tsakalozou, Eleftheria; Fang, Lanyan; Bi, Youwei; Van Den Heuvel, Michiel; Ahmed, Tausif; Tsang, Yu Chung; Lionberger, Robert; Rostami-Hodjegan, Amin; Zhao, Liang

• Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023

  Tsakalozou, Eleftheria; Gong, Yuqing; Babiskin, Andrew; Hu, Meng; Mousa, Youssef; Walenga, Ross; Wu, Fang; Yoon, Miyoung; Raney, Sam G; Polli, James E.; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang