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KMID : 1142220220170020151
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 2 p.151 ~ p.161
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The Stability Evaluation of National Biological Reference Standards to Secure Quality of Biologics
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Kang Min-Su
Park Tae-Jun
Woo Hee-Won
Park Eun-Hye
Kim Ji-Hwa
Heo Hye-Ryeon
Lee Chul-Hyun
Chun Hyung-Ok
Ryu Seung-Rel
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Abstract
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National reference standards for biologicals are reference material used for national rot release, quality control, and research of biologicals. In order to efficiently manage established national reference standards and secure high reliability, it is very important to maintain the stability of the potency and content. The purpose of our study was to secure the reliability of national reference standards through real-time stability testing of 7 national standard products for blood products. Since biologics are biologically derived and have complex chemical structures, each item has different characteristics. So stability tests are performed according to the characteristics of each item. A stability test was performed to measure the potency, and the trend was confirmed by statistical analysis of the test results from the time of manufacture. As a result of statistical analysis, it was found that stability was maintained in all items. The results of the real-time stability evaluation of national reference standards obtained through this study will be used to prepare management plans for national reference standards and to improve professionalism as a national standard quality control institution. It is expected to ultimately contribute greatly to the supply of safe and high-quality biologics.
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KEYWORD
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National referencel standard, biologics, Stability evaluation
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