Back to Agenda
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)
Shinya Suzuki
Director, Planning & Administration Group,Technology Research & Development Mgmt, Sumitomo Dainippon Pharma Co., Ltd., Japan
Prospective Issues of Trilateral BE Guidelines
Noriyuki Muranushi, PHD
Associate Director, Formulation R&D Center, CMC R&D Division, Shionogi & Co., Ltd., Japan
'Biowaiver' and 'BA/BE in Drug Development' Considered from Substance of in vivo BE Study
Hiroko Shibata
Senior Researcher, Division of Drugs, National Institute of Health Sciences, Japan
Issues with Bioequivalence for Parenteral Formulations
Have an account?