Statistical Methods for Biotechnology Products－Statistical Analysis of Stability Data
Date Issued
2006
Date
2006
Author(s)
DOI
246246/2006092815540143
Abstract
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."
Publisher
臺北市:國立臺灣大學農藝學系
Type
learning object
File(s)![Thumbnail Image]()
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Name
biotechnology07.ppt
Size
1.1 MB
Format
Microsoft Powerpoint
Checksum
(MD5):28ea201534c2263c4bc270efa3a845f1