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(110)
• Posters(37)
• Presentations(56)
• Papers(17)

• Batch-to-Batch Pharmacokinetic Variability of Orally Inhaled Drug Products

  Li, Matt (Zhichuan)

• Dose-Scale (Emax) Modeling in Pharmacodynamic Bioequivalence Studies – FDA Perspective

  Li, Matt

• Predictive Performance of PBPK Dose Estimates for Pediatric Trials

  Dallmann, Andre

• Development and Comparison of Model-based Bioequivalence Analysis Methods on Sparse Data

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

• Model-based Approaches as Guidance to Bioequivalence Decision Making: Design and Analysis Considerations

  Hooker, Andrew

• Correlating The In Vitro Dissolution Behavior Of Inhalation And Nasal Drug Products With In Vivo Performance: Pitfalls And Potential Solutions Using The Transwell System

  Hochhaus, Guenther

• Mechanistic in Silico Inference of Dermal Absorption for Chemical Risk Assessment

  Troutman, John

• A Workflow for Mechanistic Dermal Model Optimization and In Vitro-In Vivo Inference

  Hamadeh, Abdullah

• Alternative Model-Based Data Analysis Approach to Demonstrate Bioequivalence

  Gong, Yuqing

• Drug-Disease Modeling Approach to Describe the Relationship Between Long-Acting Methlyphenidate Exposure and Clinical Response

  Gomeni, Roberto