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(159)
• Posters(46)
• Presentations(74)
• Papers(39)

• Clinical Practice Data to Aid Narrow Therapeutic Index Drug Classification

  Cohen-Wolkowiez, Michael

• Levetiracetam Characterization: Is it an NTI Drug?

  Clarke, William

• Model-based Bioequivalence Evaluation for Ophthalmic Products Using Model Averaging Approaches

  Chen, Xiaomei; Hooker, Andrew; Nyberg, Henrik; Karlsson, Mats

• Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol ExtendedRelease Case Study

  Brown, Joshua

• Risk Factors Related to Relative Bioavailability Studies for Pediatric Products

  Guy, Richard

• Regulatory Perspective on Modeling Strategies Across Multiple Submissions

  Babiskin, Andrew; Yoon, Miyoung

• Assessing Bioequivalence for Generic Extended Release Formulations

  Babiskin, Andrew

• Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions

  Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaofei; Babiskin, Andrew; Yoon, Miyoung; Zhao, Liang; Fang, Lanyan

• Model-Integrated Bioequivalence Method for Highly Variable Drugs with Long Half-Life: a Simulation Study Comparing Complete Washout and Incomplete Washout Designs

  Huang, Zhe; Chen, Xiaomei; Donnelly, Mark; Fang, Lanyan; Zhao, Liang; Karlsson, Mats O; Hooker, AC

• Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions

  Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaolei; Babiskin, Andrew