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)

• Extrapolation of Pharmacokinetics Bioequivalence to an Alternative Comparator Due to RLD/RS Unavailability

  Gong, Yuqing

• The Development and Framework of Model Master Files as a Regulatory Initiative

  Tsakalozou, Eleftheria

• Using Modeling and Simulation to Correct Carryover for Long Half-Life Drug with Incomplete Washout

  Ozdin, Deniz; Chung, Min Tzu

• Considerations of Bioequivalence Studies for Long-Acting Injectables and the Application of Model-Integrated Evidence Approaches

  Gong, Yuqing

• Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use

  Fang, Lanyan (Lucy)

• Enabling the Conduct of Patient Pharmacokinetics Bioequivalence Studies Using Model-Integrated Evidence

  Gong, Yuqing

• Model Master File: How to Develop and Submit One?

  Tsakalozou, Eleftheria

• Controlled Correspondence on Clinical Pharmacology Topics in Generic Drug Development

  Donnelly, Mark

• Introduction and Overview of the Model Master File

  Fang, Lanyan

• Best Practices to Leverage Model-Integrated Evidence and Model Master File Packages to Bring Complex Generics to Market

  Ghosh, Priyanka