Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1223266 | Journal of Pharmaceutical and Biomedical Analysis | 2008 | 9 Pages |
Abstract
The following defines stability testing in the diagnostic and pharmaceutical industries as a process which, depending on the manufacturer's current approach, may contain many opportunities for improvement. Statistical thinking and six sigma concepts will enhance stability testing process capability and lead to higher confidence in the data. Tools for set up and the rationale behind them are provided to assist in establishing appropriate criteria and volume of testing.
Keywords
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Karl De Vore,