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Session 5: Innovative Methods for Assessment of Complex Generic Products
Session Chair(s)
Jingyu (Julia) Luan, PhD
Executive Regulatory Science Director , AstraZeneca, United States
Cristiana Mayer, DRSc, PhD
Head of Biostatistics, Johnson & Johnson Vision, United States
Learning Objective : At the conclusion of this session, participants should be able to:- Define complex generics
- Describe GDUFA II enhancements for complex generics
- Understand the unique challenges in the assessment in complex generics from statistical, clinical, and regulatory perspectives
Speaker(s)
Robert A. Lionberger, PhD
Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA, United States
Innovative Approaches for Complex Generics
Sarfaraz Niazi, PhD
Adjunct Professor of Biopharmaceutical Sciences, University of Illinois, United States
Meaning of Complexity of Generics
Stella C. Grosser, PhD, MS
Division Director, Office of Biostatistics, OTS, CDER , FDA, United States
The Bioequivalence of Complex Generic Drug Products
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