Statistical Methods for Biotechnology Products－Regulatory Requirements of Drug Stability
Date Issued
2000-01-23
Date
2000-01-23
Author(s)
DOI
246246/2006092815540122
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
Publisher
臺北市:國立臺灣大學農藝學系
Type
learning object
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Name
biotechnology04.ppt
Size
776.5 KB
Format
Microsoft Powerpoint
Checksum
(MD5):49a37bf99e77300f91abf5222c9258dd