Oral 21:Pharmaceutical Synthesis・Quality Control 3

[1-MO21-3] Validation and regulatory approval of endotoxin test method using archived standard curve

Atsuo Waki¹、Kazuko Iwakuma¹、Jun Toyohara²、Yukiko Komatsu⁵、Ichiro Ando³、Tomomi Shinke⁴、Toshimitsu Watanabe⁹、Tetsuya Mori⁶、Kazuyoshi Honjo⁷、Kenichi Nishijima⁸ (1.Qulity Assurance and Audit Office, National Institute for Quantumn Science and Technology, Chiba, Japan、2.Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan、3.Hamamatsu Medical Imaging Center, Hamamatsu Medical Photonics Foundation, Hamamatsu, Japan、4.PET Business Promotion Group, Department of Business Create Support, Global Strategic Challenge Center, Hamamatsu Photonics K.K. Hamamatsu, Japan、5.Medical Cooperation Teishinkai Central CI Clinic, Sapporo, Japan、6.Biomedical Imaging Research Center, University of Fukui, Fukui, Japan、7.Nippon Medical School Clinical Imaging Center for Healthcare, Tokyo, Japan、8.Advanced Clinical Research Center, Fukushima Medical University, Fukushima, Japan、9.Sumitomo Heavy Industries, Ltd.)