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원윤정(Won, Yoon-Jung),진보라(Jin, Bo-ra),김동윤(Kim, Dong-Yun) 한국실내디자인학회 2014 한국실내디자인학회 학술대회논문집 Vol.2014 No.5
As the human’s life becomes convenient, the problem of disposing mass trash and resource exhaustion problem are becoming serious. As an alternative to these problems, the recycle and recycled design are emerging as a big concern. This study is designed to examine the concept of recycle design and necessity and consider the methodology of the sustainable design focusing the environment-friendly design through the case of furniture reborn by recycling. Also, as the awareness on the recycle design changes positively and new values on the environment are created, people are expected to recognize human and environment coexist.
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생물학적제제의 치메로살 함량 정량을 위한 가열기화 아말감 흡광도법의 확립 및 검증
김병철,김도근,홍성화,김연희,임종미,원윤정,김석환,홍지영,윤영민,김재옥,Kim, Byung-Chul,Kim, Do-Keun,Hong, Sung-Hwa,Kim, Yeon-Hee,Lim, Jong-Mi,Won, Yun-Jung,Kim, Seok-Hwan,Hong, Ji-Young,Yun, Young-Min,Kim, Jae-Ok 대한약학회 2011 약학회지 Vol.55 No.4
The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.
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수두생바이러스백신 국가표준품 (2차) 제조 및 확립에 관한 연구
김연희(Yeon Hee Kim),김도근(Dokeun Kim),손여원(Yeo Won Sohn),한의리(Euiri Han),김석환(Seok Hwan Kim),임종미(Jong-Mi Lim),원윤정(Yun Jung Won),윤희성(Heui Seong Yoon),조문희(Moon Hee Jo),김관수(Kwan Soo Kim),김재욱(Jaeok Kim) 한국생물공학회 2010 KSBB Journal Vol.25 No.6
수두 생바이러스 백신과 같은 생물의약품은 다양한 물질이 복합적으로 구성되어 있어 단순한 물리·화학적 분석방법만으로는 그 특성을 규명할 수 없다. 따라서 이러한 생물의약품의 품질을 평가하기 위해서는 표준품이 필수적이다. 2002년과 2003년에 제조 및 확립한 1차 국가표준품의 재고량 소진 및 역가 감소에 따라 식품의약품안전평가원에서는 수두 생바이러스 백신의 2차 국가표준품을 확립하기 위하여 2008년 용역연구사업을 통해 국내의 수두 생바이러스 백신 제조회사에서 표준품 후보물질을 제조하였으며, 국가표준품후보물질의 역가산정을 위하여 국내 제조사 및 식품의약품안전평가원에서 공동연구를 수행하였다. 국내제조사를 포함한 3개의 공동연구 시험소에서 7회 이상의 반복시험을 수행하여 얻은 공동연구 결과를 통계학적으로 분석한 결과 3곳의 공동연구 시험소의 통합역가에 대한 변이계수 (coefficient variation, CV)는 1.24%로 각 시험소간의 기하평균 (GMT) 변동 수준이 매우 낮음을 확인할 수 있었다. 또한, 수두 생바이러스 백신의 2차 국가표준품의 표시역가는 4.26 log10 PFU/0.5 mL로 산정하였다. Biological products, such as live varicella vaccine, are composed of biological substances derived from biological organisms. It is very difficult to identify these biologics’ characteristics by analysis of simple physical and chemical methods alone. So the reference material is essential in order to evaluate the quality of bilogics. The 1’st national standard for varicella live vaccine was manufactured, established in 2002 and 2003, and have been used for the manufacturer’s quality control and national lot release since then. As the lack of its availability and the decrease of its stability, this study was initiated by National Institute of Food and Drug Safety Evaluation (NiFDS) in 2008 to manufacture and establish the 2nd national standard for varicella live vaccine. The candidate material was manufactured from one of domestic manufacterers and the joint research of the NiFDS and manufacturers of varicella live vaccine was conducted to estimate of the reliable virus content. In the collaborative study, 3 laboratories including NiFDS performed the virus content test more than 7 times and all assay results were statistically analyzed. The mean coefficient of variation (CV) was 1.24%, and the geometric mean titre (GMT) variation range of each laboratory was low. On the basis of the results of this study, the candidate material of 2nd national standard for varicella live vaccine was assigned a potency of 4.26 log10 pfu/0.5 mL, when reconstituted in 0.7 mL.
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