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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, BioPharmaceuticals R&D
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)
Innovative Approaches for Complex Generics
Robert A. Lionberger, PhD
FDA, United States
Director, Office of Research and Standards, Office of Generic Drugs, CDER
Meaning of Complexity of Generics
Sarfaraz Niazi, PhD
University of Illinois, United States
Adjunct Professor of Biopharmaceutical Sciences
The Bioequivalence of Complex Generic Drug Products
Stella C. Grosser, PhD, MS
FDA, United States
Division Director, Office of Biostatistics, OTS, CDER
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