GDUFA Research Outcomes

QCP Methods

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

• Model-Integrated Methods and Innovative Study Designs for Generic LAI Product Development and Regulatory Assessment

  Hooker, Andrew

• 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

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

  Hamadeh, Abdullah

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

  Troutman, John

• Considerations and Challenges of Pharmacokinetics Bioequivalence Studies for LAIs and the Application of Model-Integrated Evidence (MIE) Approaches

  Gong, Yuqing

• Strategic Development of Generic Long-Acting Injectables: Model-Integrated Evidence Approaches

  Gong, Yuqing

• 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