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頁籤選單縮合
題名 | B型肝炎疫苗效價試驗用標準品之製備 |
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作者 | 林嘉伯; | 書刊名 | 藥物食品分析 |
卷期 | 1:1 1993.01[民82.01] |
頁次 | 頁43-48 |
分類號 | 418.293 |
關鍵詞 | B型肝炎疫苗; 效價; Hepatitis B vaccine; Reference standard; Potency test; |
語文 | 中文(Chinese) |
英文摘要 | A well qualified plasma derived hepatitis B vaccine, coded 028A, was evaluated in the National Laboratories of Foods and Drugs for its potency to serve as the first national reference standard for hepatitis B vaccine for use in immunogenicity assays. This proposed national reference standard was assayed against the WHO plasma-derived hepatitis B reference standard, lot 96932. The relative potencies of lot 028A plasma-derived hepatitis B vaccine versus WHO lot 96932 vaccine was evaluated in a series of immunization studies for both guinea pig and Balb/c mouse groups by the parallel line assay method.Results obtained indicated that the relative potencies for the guinea pig and mouse groups were 1.04 ± 0.12 and 1.09 ± 0.39, respectively. This reference standard is intended for use in assays of hepatitis B vaccines in both mouse or guinea pig immunogenicity studies for the vaccine sealing tests in Taiwan. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。