DIAGNOSTIC EFFECTIVENESS OF QUANTITATIVE [18F]FLUTEMETAMOL PET IMAGING IN SUBJECTS WITH NORMAL PRESSURE HYDROCEPHALUS USING BIOPSY HISTOPATHOLOGY STANDARD OF TRUTH FOR DETECTION OF FIBRILLAR AMYLOID B

Abstract

frequently involve multiple steps, and the crude reaction mixture is usually purified by HPLC. Since PET imaging drugs are typically administered intravenously, procedures must be de veloped to produce them which are sterile and pyrogen free, and manufactured under th e guidance of GMP standards, whenever conducted in human. Methods: Although there are several kinds of SYNTHESIZERs for PET imaging drugs in the world, NEPTIS is adopted for the commercial production of amyloid PET imaging drug, florbetapir in the US and Europe. While in Japan, MPS200Ab was developed and is now applied for NDA for the manufacturing of florbetapir by Sumitomo Heavy Industries. In order to achieve the equivalency in terms of the QC of florbetapir produced by between NEPTIS and MPS200Ab, socalled three lots-productions and analytical system suitability tests are conducted at Tokyo Metropolitan Institute of Gerontology, and the equivalency between two synthesizers is well established. Results: The detailed conditions and results of three lots-productions and analytical system suitability tests will be presented at the AAIC2014. Conclusions:MPS200Ab is originally developed by Sumitomo Heavy Industries and is characterized by several advantages over the conventional synthesizers. The solid-phase extraction system consolidated in MPS200Ab is one of the most characteristic points which is resulted in the high-degreed purification and the efficient procedure. We believe amyloid PET imaging drug, florbetapir will be applied safely and widely in Japan by MPS200Ab for the early diagnosis and the therapeutic approach.