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頁籤選單縮合
題 名 | Light-Sensitive Cold Kits and the Associated Radiopharmaceuticals=對光敏感套組與相關放射性藥品 |
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作 者 | 洪家瑤; | 書刊名 | 核子醫學雜誌 |
卷 期 | 16:4 2003.12[民92.12] |
頁 次 | 頁185-190 |
分類號 | 418.346 |
關鍵詞 | 對光穩定性; 套組; 放射性藥品; 美國藥典; 仿單; 美國食品暨藥物管理局; Photostability; Cold kits; Radiopharmaceuticals; United States pharmacopeia; Package insert; U.S. food and drug administration; |
語 文 | 英文(English) |
中文摘要 | 對光敏感的藥品原料與藥物產品(包括套組與放射性藥品)必須適當地包裝與貯存,以維持使用時之最佳品質、力價與純度。有兩種資訊來源提供這些藥品原料與產品的包裝、標籤與貯存,此即美國藥典和藥廠提供的仿單。然而就對光敏感的套組與放射性藥品的包裝、貯存與標籤而言,這些正式的資訊來源有許多矛盾與不一致之處。本文目的即為確認任何有可能損傷及易受光誘導分類之套組完整性及其配製的放射性藥品之矛盾部分。我期待美國藥編撰機構(the United States Pharmacopeial Convention, Inc.)、美國食品暨藥物管理的,以及藥廠能共同努力解決這些矛盾與不一致。 |
英文摘要 | Light sensitive drug substance(s) and/or drug products (including cold kits and radiopharmaceuticals) must be properly packaged and stored in order to maintain the optimum quality, strength, and purity with regard to their intended usage. There are two sources available for information concerning the packaging, labeling, and storage of these drug substance(s)/products, i.e., United States Pharmacopeia and the manufacturers package inserts. However, there are numerous discrepancies and inconsistencies exist in both of these official sources of information with regard to the packaging, storage, and labeling of light-sensitive cold kits and radiopharmaceuticals. The prupose of this article is to identify any discrepancies that may compromise the integrity of cold kits and reconstituted radiopharmaceuticals that are prone to light-induced degradation. It is my hope that the United States Pharmacopeial Convention, Inc., the U.S. Food and Drug Administration, as well as the manufacturers, can work together to overcome these deficiencies and inconsistencies. |
本系統中英文摘要資訊取自各篇刊載內容。