https://scholars.lib.ntu.edu.tw/handle/123456789/184688
標題: | Statistical Methods for Biotechnology Products-Statistical Analysis of Stability Data | 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: | Stability data from long-term studies under ambient conditions ( nonaccelerated data). Shelf-life FDA Guideline(1987) p.29"to establish, with a high degree of confidence, an expiration dating period during which the average drug product characteristic(i.e.,strength) of the batch will remain within specifications. This expiration dating period should be applied to all future batches..." p.30"Also, percent of label claim, not percent of initial average-value, is the variable of interest." |
URI: | http://ntur.lib.ntu.edu.tw//handle/246246/2006092815540143 | 其他識別: | 246246/2006092815540143 |
顯示於: | 農藝學系 |
檔案 | 描述 | 大小 | 格式 | |
---|---|---|---|---|
biotechnology07.ppt | 1.13 MB | Microsoft Powerpoint | 檢視/開啟 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。