https://scholars.lib.ntu.edu.tw/handle/123456789/184684| Title: | Statistical Methods for Biotechnology Products－USP Tests and Specifications | Authors: | Liu, Jen-Pei | Issue Date: | 2006 | Publisher: | 臺北市:國立臺灣大學農藝學系 | Abstract: | 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 | Other Identifiers: | 246246/2006092815540133 |
| Appears in Collections: | 農藝學系 |
| File | Description | Size | Format | |
|---|---|---|---|---|
| biotechnology03.ppt | 1.05 MB | Microsoft Powerpoint | View/Open |
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