Development of Good Manufacturing facility for Radiopharmaceuticals
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Shin, Byung-Chul
(Division of Radioisotope Production & Application, Korea Atomic Energy Research Institute)
Choung, Won-Myung (Division of Radioisotope Production & Application, Korea Atomic Energy Research Institute) Park, San-Hyun (Division of Radioisotope Production & Application, Korea Atomic Energy Research Institute) Lee, Kyu-Il (Division of Radioisotope Production & Application, Korea Atomic Energy Research Institute) Park, Kyung-Bae (Division of Radioisotope Production & Application, Korea Atomic Energy Research Institute) Park, Jin-Ho (Division of Radioisotope Production & Application, Korea Atomic Energy Research Institute) |
1 | Rules and Guidance of Pharmaceutical Manufacturers, HMSO, U.K. (1993) |
2 | TRS 36th Report, WHO Expert Committee on Specifications for Pharmaceutical Preparations, 14. JUL. (1999) |
3 | WHO TRS No. 908, 'Good manufacturing practices for pharmaceutical products', (2003) |
4 | FDA GMP Part 21O/211-Current good manufacturing practice (1992) |
5 | 미국연방규격(U.S. Federal Standard) 209E (1992) |
6 | 미국항공우주국규격(NASA Standard) NHB 5340.2 (1992) |
7 | ANS, Design Guides for Radioactive Material Handling Facilities and Equipment (1988) |
8 | 한국방사성동위원소협회, 원자력관련고시집 (2001) |
9 | KGMP 해설서, 보건복지부 (2002) |
10 | 박진호 외 'Fission Mo-99 생산기술개발' (KAERI-RR-2008/99) (2000) |
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