Browse > Article
http://dx.doi.org/10.7742/jksr.2013.7.6.397

Suggestion for Good Manufacturing Practice of Radiopharmaceuticals  

Shin, Byungchul (Nuclear Training & Education Center, Korea Atomic Energy Research Institute)
Lee, Sangbock (Dept. of Radiology Nambu University)
Publication Information
Journal of the Korean Society of Radiology / v.7, no.6, 2013 , pp. 397-402 More about this Journal
Abstract
This study suggests considerations for legislation of radiopharmaceutical manufacturing practice according as the Korea Pharmaceutical Affairs Act and guidelines on foreign radiopharmaceutical manufacturing practice. Pharmaceuticals should be verified safety, effectiveness, and uniformity. Therefore, it is expected that the efficiency of the administration of radiopharmaceuticals increase and nation's health promote if rational manufacturing management to consider of radiopharmaceutical properties is legislated.
Keywords
Pharmaceutical Affairs Act; radiopharmaceutical; manufacturing practice; uniformity;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Guideline on PET Radiopharmaceuticals, KFDA, 2012.
2 Manufacture of Radiopharmaceuticals, KFDA, 2010.
3 http://blog.daum.net/poemandstar/13076771
4 http://www.dreamdrug.com/News/172873
5 Byungchul Shin, Wonmyung Choung, Jinho Park, Kyungbae Park "Facilities for Research and Development of Medical Radioisotopes", KAERI/RR-2383/2002, KAERI, 2003.
6 Nuclear Theory, KAERI/NTC/RI/2009-01, KAERI, 2009.
7 Guidance PET Drugs-CGMP, December 2009.
8 The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 3 Manufacture of Radiopharmaceuticals, September 2008.
9 http://sbscnbc.sbs.co.kr/read.jsp?pmArticleId=10000387237