https://scholars.lib.ntu.edu.tw/handle/123456789/184684
標題: | Statistical Methods for Biotechnology Products-USP Tests and Specifications | 作者: | Liu, Jen-Pei | 公開日期: | 2006 | 出版社: | 臺北市:國立臺灣大學農藝學系 | 摘要: | Identity, strength, quality, and purity of a drug product. Sampling plan and acceptance criteria required by USP XXII/NF XVII for content uniformity testing [905] dissolution testing [711] disintegration testing [701] Approximate probabilities can be computed for passing USP testing. Acceptance limits also can be established to pass USP testing with a high probability. Tolerance limit approach can be used to set up the in-house specifications. |
URI: | http://ntur.lib.ntu.edu.tw//handle/246246/2006092815540133 | 其他識別: | 246246/2006092815540133 |
顯示於: | 農藝學系 |
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biotechnology03.ppt | 1.05 MB | Microsoft Powerpoint | 檢視/開啟 |
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