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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)
Lawrence Yu, PHD
Director, Office of New Drug Products, OPQ, CDER, FDA, United States
BCS Biowaiver of Human BE Study: Current Status and Future Perspective in US
Yutaka Takahashi
Senior Manager, Pharmaceutical Planning & Control, Astellas Pharma Inc., Japan
Scientific Approach to Availability of IVIVC for Japan
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