頁籤選單縮合
題名 | 藥品安定性研究綜論=An Overview of Stability Studies |
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作者 | 林慧; 周賢忠; Ju, Huey Lin; Chow, Shein-chung; |
期刊 | 藥物食品分析 |
出版日期 | 19960600 |
卷期 | 4:2 1996.06[民85.06] |
頁次 | 頁99-106 |
分類號 | 418.02 |
語文 | chi |
關鍵詞 | 退化曲線; 藥品架儲期; 有效期限; 加速試驗; Degradation curve; Shelf-life; Expiration dating period; Accelerating testing; |
英文摘要 | Before any drug products are marketed, it is required by the government regulatory agencies that stability studies to be conducted. The objective of the stability studies is not only to characterize the degradation curve but also to estimate the shelf-life of the drug products. The estimated shelf-life gives a certain assurance that the drug products retains its identity, strength, quality and purity during the time period. In this paper, we give an overview of the stability studies, which includes the historical background, comparisons of guidelines among various countries, recent developments, as well as future research topics. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。