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Contents 1 2 Eu – US PFI User Guide Introduction ....................................................................................................................................... 4 1.1 Overview..................................................................................................................................... 4 1.2 Scope........................................................................................................................................... 4 1.3 Purpose ....................................................................................................................................... 5 Getting started ................................................................................................................................... 6 2.1 Log in .......................................................................................................................................... 6 2.2 Why Registration ........................................................................................................................ 8 2.3 New user registration ................................................................................................................ 10 2.4 Forgot Login Email................................................................................................................... 13 2.5 Regular User ............................................................................................................................. 15 2.6 Website links ............................................................................................................................ 17 3 Session expiration............................................................................................................................ 18 4 Logout ............................................................................................................................................. 19 5 Basic Search .................................................................................................................................... 21 5.1 6 7 Search by Excipient .................................................................................................................. 22 Advanced Search ............................................................................................................................. 34 6.1 Clinical Data ............................................................................................................................. 36 6.2 Non-Clinical Data ..................................................................................................................... 42 Search Results ................................................................................................................................. 49 7.1 General Information.................................................................................................................. 51 7.2 Clinical Data ............................................................................................................................. 53 7.3 Non Clinical Data ..................................................................................................................... 65 7.4 Invitro data ................................................................................................................................ 77 7.5 Regulatory Reference ............................................................................................................... 85 Introduction Page | 2