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題名 | 市售輸入第八凝血因子及第九凝血因子製劑之效價試驗調查=The Potency of Anti-Hemophilic Factor VIll and Factor Ix in Taiwan |
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作者 | 關政平; 陳苾芬; 邱進益; 林嘉伯; Kuan, Cheng-ping; Chen, Pi-fang; Chiou, Jin-yi; Lin, Chia-po; |
期刊 | 藥物食品檢驗局調查研究年報 |
出版日期 | 19971100 |
卷期 | 15 1997.11[民86.11] |
頁次 | 頁56-59 |
分類號 | 418.23 |
語文 | chi |
關鍵詞 | 第八凝血因子; 第九凝血因子; 效價試驗; |
中文摘要 | 為瞭解市售輸入凝血因子血液製劑之品質,於民國八十四年七月至八十五年六月 間,由臺灣地區該類藥品代理商處直接抽購檢體計10件,含第八凝血因子(Factor VIII) 9件第九凝血因子(Factor IX complex)1件。分別依原廠之方法做適當修正測定其凝血時間 ,並計算其相對效價。結果第八凝血因子及第九凝血因子效價均符合我國「生物製劑檢驗基 準」之規定。 |
英文摘要 | In order to evaluate the qality of imported antihemophilic factor VIII and factor IX in Taiwan, potency tests were conducted on nine samples of factor VIII and one sample of factor IX purchased randomly from the Taiwan representative of 10 overseas manufacturers between July 1995 and June 1996. All these samples were assayed according to the analytical protocols provided by the manufactures's with some modifications. All the samples met the Minimum Requirements of Biological Standard. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。