同位素 ›› 2001, Vol. 14 ›› Issue (Z1 ): 241-241 .DOI: 10.7538/tws.2001.14.Z1.0241

• 论文 • 上一篇    下一篇

PET放射性药物的质量保证和质量控制

作者   

  1. @党淑琴$中国原子能科学研究院同位素研究所!北京102413 @夏振民$中国药品生物制品检定所!北京100050
  • 收稿日期:2000-12-28 出版日期:2001-10-20 发布日期:2001-10-20

Quality Assurance and Quality Control of PET-radiopharmaceuticals

  1. DANG Shu qin 1, XIA Zhen min 2 (1.Department of Isotope, China Institute of Atomic Energe, Beijing 102413, China; 2.National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China)
  • Received:2000-12-28 Online:2001-10-20 Published:2001-10-20

摘要: 随着我国高能正电子断层显像技术应用的迅速开展 ,研制和开发符合标准的正电子药物应用于临床已是当务之急。由于正电子放射性药物寿命短 ,迫使人们必须建立质量控制的新概念。质量控制是强调法规控制下研制和生产过程的质量保证 ,最终产品的质量检验只作为此类药物质量证明的补充

关键词: PET放射性药物, 质量控制(QC), 药物研制管理规范(GLP和GCP), 药品生产管理规范(GMP/GRP), 质量保证(QA)

Abstract: It is an urgent matter to research and develop the PET radiopharmaceuticals, which is up to the national standard for clinical use keeping pace with the growth of application of PET in China. Time factor necessitates new concepts of quality control (QC) to be strength, which is the quality assurance (QA) under the regulatory control for this kind of radiopharmaceuticals, the action of the routine test for finished products is regarded as a complementary testimony of the quality.

Key words: radiopharmaceuticals for PETquality control (QC), good laboratory practice (GLP) and good clinical practice (GCP), good manufacture practice (GMP) or good radiopharmacy practice (GRP), quality assurance(QA)

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