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Session 2: Scientific Approach of BE Study
Session Chair(s)
Kazuhiro Okochi
Associate Director, GMS Japan Quality Center
Takeda Pharmaceutical Company Limited, Japan
Scientific Approach of BE Study
Speaker(s)
BCS Biowaiver of Human BE Study: Current Status and Future Perspective in US
Lawrence Yu, PHD
FDA, United States
Director, Office of New Drug Products, OPQ, CDER
Scientific Approach to Availability of IVIVC for Japan
Yutaka Takahashi
Astellas Pharma Inc., Japan
Senior Manager, Pharmaceutical Planning & Control
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