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)

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

  Fang, Lanyan(Lucy).

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

  Fang, Lanyan

• Is Bioequivalence Established in Adults Relevant for Pediatrics?

  Fang, Lanyan; Sherwin, Catherine

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

  Fang, Lanyan

• Leveraging Quantitative Methods in Reviewing Complex/Locally Acting Products

  Fang, Lucy

• Physiologically-Based Pharmacokinetic Pediatric Skin Model

  Edginton, Andrea; Yun, Esther; Hamadeh, Abdullah

• Regulatory Challenges with Pharmacokinetic (PK) Bioequivalence (BE) Studies for Drugs Containing Endogenous Compounds

  Donnelly, Mark

• Pharmacometric Approach To Define Narrow Therapeutic Index (NTI) Drugs & Evaluate Bioequivalence (BE) Criteria for NTI Drugs

  Dahmane, Elyes; Gobburu, Joga; Ivaturi, Vijay

• Use of Clinical Practice Data and PK/PD Modeling to Aid Classification of Narrow Therapeutic Index Drugs

  Cohen-Wolkowiez, Michael

• Clinical Practice Data to Aid Narrow Therapeutic Index Drug Classification

  Cohen-Wolkowiez, Michael