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.
-
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
-
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