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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
Director, Planning & Administration Group,Technology Research & Development Mgmt, Sumitomo Dainippon Pharma Co., Ltd., Japan
'Biowaiver' and 'BA/BE in Drug Development' Considered from Substance of in vivo BE Study
Noriyuki Muranushi, PhD
Associate Director, Formulation R&D Center, CMC R&D Division, Shionogi & Co., Ltd., Japan
Issues with Bioequivalence for Parenteral Formulations
Hiroko Shibata
Senior Researcher, Division of Drugs, National Institute of Health Sciences, Japan
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