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)

• Recommendation of Partial Area Under the Curve (pAUC) Metrics in Product-Specific Guidance for Long-Acting Injectable (LAI) Drug Products

  Thomas, Sherin

• 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

• Leveraging Quantitative Methods in Reviewing Complex/Locally Acting Products

  Fang, Lucy

• Is Bioequivalence Established in Adults Relevant for Pediatrics?

  Fang, Lanyan; Sherwin, Catherine

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

  Fang, Lanyan(Lucy).

• Is Bioequivalence Established in Adults Relevant for Pediatrics?

  Fang, Lanyan

• Symposium 14: Applying Pharmacometrics to Precision Dosing in the Lifecycle of Long-acting Injectable Products: Drug Development, Regulatory Approval & Clinical Practice

  Fang, Lanyan

• Marriage between Quantitative Approaches and Regulatory Science: A Reality Check on Where We Are

  Fang, Lanyan

• Physiologically-Based Pharmacokinetic Pediatric Skin Model

  Edginton, Andrea; Yun, Esther; Hamadeh, Abdullah