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Volume 58, Issue 6
Displaying 1-4 of 4 articles from this issue
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Materials(Data)
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Medical Science and Pharmaceutical Committee, Japan Radioisotope Assoc ...2009 Volume 58 Issue 6 Pages 221-245
Published: 2009
Released on J-STAGE: June 29, 2009
JOURNAL OPEN ACCESSFor 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.View full abstractDownload PDF (455K) -
Subcommittee on Medical Application of Positron Emitting Radionuclides ...2009 Volume 58 Issue 6 Pages 247-289
Published: 2009
Released on J-STAGE: June 29, 2009
JOURNAL OPEN ACCESSThis document summarizes technological issues, supplementary information and descriptions for items covered in the “Standards of Compounds Labeled with Positron Emitting Radionuclides Approved as Established Techniques for Medical Use:approved by the Subcommittee on Medical Application of Positron Emitting Radionuclides(revised in 2009)” to facilitate effective and appropriate use of said established standard techniques. Each facility should have a committee and establish internal system to account for manufacturing compounds labeled with positron emitting radionuclides produced in its facility, and compile standards by referring to the “Standards of Compounds Labeled with Positron Emitting Radionuclides Approved as Established Techniques for Medical Use:approved by the Subcommittee on Medical Application of Positron Emitting Radionuclides(revised in 2009)”, so as to secure the quality of radiopharmaceuticals.View full abstractDownload PDF (1654K) -
Subcommittee on Medical Application of Positron Emitting Radionuclides ...2009 Volume 58 Issue 6 Pages 291-442
Published: 2009
Released on J-STAGE: June 29, 2009
JOURNAL OPEN ACCESSDownload PDF (4034K) -
Japan Radioisotope Association Medical Science and Pharmaceutical Comm ...2009 Volume 58 Issue 6 Pages 443-454
Published: 2009
Released on J-STAGE: June 29, 2009
JOURNAL OPEN ACCESSThe recent advancement and prevalance of clinical application of positron emission tomography(PET)have forced us to review previsous manuscript of “Standards of compounds labeled with positron emitting radionuclides approved as established techniques for medical use and recommendations on practices of their clinical use”. Subcommittee on Medical Application of Positron Emitting Radionuclides of Medical Science and Pharmaceutical Committee in Japan Radioisotope Association has reviewed standards and recommendations for clinical use. Similar to the previous version of recommendations on practices of clinical use, this version includes “clinical purpose”, “principle of measurement”, “methods of administration”, and “radiation exposure” of particular PET pharmaceuticals.
This version includes 12 PET ligands 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 approved compounds(18F-sodium fluoride, 11C-raclopride, and 11C-flumazenil)which have been required for clinical use in many medical instutites.
Each medical institue should have a committee and establish internal system to account for conducting clinical use of radiolabeled compounds.View full abstractDownload PDF (870K)
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