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| 題 名 | F-18 FDOPA注射液之美國藥典與歐洲藥典品管標準與方法比較=A Comparison of Criteria and Methods for Quality Control Tests of F-18 FDOPA between USP and EP |
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| 作 者 | 黃雅瑤; 曾凱元; 高志浩; | 書刊名 | Annals of Nuclear Medicine and Molecular Imaging |
| 卷 期 | 27:4 2014.12[民103.12] |
| 頁 次 | 頁220-228 |
| 分類號 | 418.346 |
| 關鍵詞 | 歐洲藥典; 品管; 美國藥典; Fluorodopa F18 Injection; EP; F-18 FDOPA; Quality control; USP; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 6-[F-18]-fluoro-L-3,4-dihydroxy-phenylalanine (F-18 FDOPA)已廣泛應用於神經科學與腫瘤學相關臨床應用,如帕金森氏症(Parkinson's disease)及神經內分泌腫瘤(neuroendocrine tumor)等。因此,除了美國藥典(U.S. Pharmacopeia, USP),近來歐洲藥典(European Pharmacopeia, EP)也已列出F-18 FDOPA的品管項目及方法。本文即針對最新版USP與EP中所列之F-18 FDOPA品管項目以及品管方法進行一比較與討論,希望可以協助其他F-18 FDOPA之生產單位與使用單位確保其注射液之品質符合國際標準。甚至希望可以藉由本文促進相關單位之合作以建立更符合臺灣與世界現況之相關正子藥物法規。 |
| 英文摘要 | 6-[F-18]-fluoro-L-3,4-dihydroxy-phenylalanine (F-18 FDOPA) has been widely applied in neuroscience and oncology, such as Parkinson’s disease, neuroendocrine tumor and so on. As a result, the acceptance criteria and test methods of the quality control (QC) tests for F-18 FDOPA via electrophilic production have been listed in the U.S. Pharmacopeia (USP) as well as European Pharmacopeia (EP). In order to assist the radiotracer producer and the user to assure that the quality of F-18 FDOPA injection is fit in with international standard, this article is proposed to compare the difference of the QC criteria and the testing methods between the latest edition of USP and EP. Furthermore, it is hope that this article will stimulate the cooperation among related associations and the competent authorities in Taiwan, and develop a set of harmonized and reasonable QC standards for F-18 FDOPA or other PET radiotracers. |
本系統中英文摘要資訊取自各篇刊載內容。