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)

• ANDA Challenges Related to Vasoconstrictor Studies

  Feng, Kairui

• Model-based Bridging to Establish Bioequivalence With a Discontinued Reference Listed Product

  Feng, Kairui

• Application of Quantitative Modeling and Simulations to Bioequivalence Determination for Long-Acting Injectables – Sharing Research Progress and Regulatory Experience

  Feng, Kairui

• Applications and Lessons Learned for Conducting Adaptive Designs in Generic Drug Development

  Feng, Kairui

• Regulatory Considerations in Development of Generic Long-Acting Injectable (LAI) Formulations for HIV Treatment and Prevention

  Fang, Lanyan

• Narrow Therapeutic Index Drug Classification: US FDA Current Process

  Fang, Lanyan

• Leveraging Modeling and Simulation to Streamline Generic Drug Development and Assessment

  Fang, Lanyan

• Partial Area Under Curve (pAUC): Product-Specific Guidance Development and Practice for Product Evaluation

  Fang, Lanyan

• Partial Area Under Curve (pAUC): Product-Specific Guidance Development

  Fang, Lanyan (Lucy)

• Is Bioequivalence Established in Adults Relevant for Pediatrics?

  Fang, Lanyan