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Session 1: Background and Philosophy of Each Region BE Guideline
Session Chair(s)
Rumiko Shimazawa, PHD
Professor, School of Medicine, Tokai University School of Medicine, Japan
Background and Philosophy of Each Region BE Guideline
Speaker(s)
Chikako Yomota
Invited Researcher, National Institute of Health Sciences, Japan
Basic Stance of Japanese BE Guidelines
Lawrence Yu, PHD
Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Evolving FDA's Bioequivalence Standards
Susana Almeida
Senior Director of European Operations, Inflamax Research Inc., Portugal
Bioequivalence: Towards Global Harmonization?
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