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Session 3: Regulatory Approach of BE Study
Session Chair(s)
Satoshi Nagayama
Principal Scientist
Pfizer Japan Inc., Japan
Regulatory Approach of BE Study
Speaker(s)
Prospective Issues of Trilateral BE Guidelines
Shinya Suzuki
Sumitomo Dainippon Pharma Co., Ltd., Japan
Director, Planning & Administration Group,Technology Research & Development Mgmt
'Biowaiver' and 'BA/BE in Drug Development' Considered from Substance of in vivo BE Study
Noriyuki Muranushi, PhD
Shionogi & Co., Ltd., Japan
Associate Director, Formulation R&D Center, CMC R&D Division
Issues with Bioequivalence for Parenteral Formulations
Hiroko Shibata
National Institute of Health Sciences, Japan
Senior Researcher, Division of Drugs
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