대한약학회:학술대회논문집 (Proceedings of the PSK Conference)
- 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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- Pages.253.2-253.2
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- 2003
Collaborative Study for the Establishment of a National Reference Preparation for Erythropoietin
- Jin, Jae-Ho (KFDA) ;
- Kim, Gi-Hyun (LGLS) ;
- Shin, Won (CJ Corp) ;
- Shin, Ji-Soon (Dong-A Pharm. Co) ;
- Choi, Jong-Yoon (Choongwae Pharma corp) ;
- Yoon, Sei-Ung (NIBS) ;
- Kim, Min-Sung (NIBS) ;
- Kim, Yang-Woo (NIBS) ;
- Lee, Seung-Woo (NIBSC)
- 발행 : 2003.04.01
초록
National regulatory authority have the duty to ensure that available pharmaceutical products are of the required quality. This is particularly difficult for biotechnological products, the quality of which cannot be established entirely by test on the material in the final container. In general biotechnological products are distinguished from other drugs by being derived from genetically modified microorganism to humans, and frequently have a complex molecular structure. (omitted)
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