Standards of Compounds Labeled with Positron Emitting Radionuclides Approved as Established Techniques for Medical Use(2009 revision)

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Other Title
  • ポジトロン核医学利用専門委員会が成熟技術として認定した放射性薬剤の基準（２００９年改定）

Abstract

For the establishment of PET diagnosis as a routinely used clinical diagnostic tool, the compliances of manufacture regulations under the Good Manufacturing Practice(GMP)principle for PET radiopharmaceuticals are necessary. For this purpose, the Subcommittee on Medical Application of Positron Emitting Radionuclides, Medical Science and Pharmaceutical Committee, in Japan Radioisotope Association has made the “Standards for Compounds Labeled with Emitting Radionuclides Approved as Established Techniques for Medical Use”. At present, there are two standards ; ones for 15O gases and 18FDG(2001 revision), whose studies have been approved by NHIS, and another for other 10 PET agents(1999 version). Thus, to promote more safe and effective application of compounds labeled with positron emitting radionuclides produced in the hospital, the Subcommittee on Medical Application of Positron Emitting Radionuclides of Medical Science and Pharmaceutical Committee in Japan Radioisotope Association has reviced standards by unifying processes and specifications of 15 compounds including 12 compounds that have been already approved as “compounds labeled with positron emitting radionuclides as established techniques for medical use” in the committee(18FDG, 15O-oxygen, 15O-carbon monoxide, 15O-carbon dioxide, 11C-monoxide, 13N-nitrogen, 13N-ammonia, 15O-water, 11C-L-methionine, 11C-sodium acetate, 11C-N-methylspiperone, and 11C-choline)and three newly compounds approved at 2009(18F-sodium fluoride, 11C-raclopride, and 11C-flumazenil). This guideline includes the general notices, general rules for preparations, general tests for the quality control, quality of each PET agents, guideline for manufacturing environment and manufacturing process at manufacturing facilities of PET agents.

Journal

  • RADIOISOTOPES

    RADIOISOTOPES 58 (6), 221-245, 2009

    Japan Radioisotope Association

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