https://scholars.lib.ntu.edu.tw/handle/123456789/184685| Title: | Statistical Methods for Biotechnology Products－Regulatory Requirements of Drug Stability | Authors: | Liu, Jen-Pei | Issue Date: | 23-Jan-2000 | Publisher: | 臺北市:國立臺灣大學農藝學系 | Abstract: | Historical milestone Pre-1975 No requirements( some drug products are known to be unstable, e.g., Penicillin ) 1975 First USP with expiration dating period clause 1984 FDA issued stability guideline 1987 Current FDA guideline 1993 WHO draft guideline 1993 ICH issued stability guideline 1994 FDA guideline being revised 2003-2005 ICH stability guidances Q1A, Q1D, Q1E, Q1F |
URI: | http://ntur.lib.ntu.edu.tw//handle/246246/2006092815540122 | Other Identifiers: | 246246/2006092815540122 |
| Appears in Collections: | 農藝學系 |
| File | Description | Size | Format | |
|---|---|---|---|---|
| biotechnology04.ppt | 776.5 kB | Microsoft Powerpoint | View/Open |
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