Article ID Journal Published Year Pages File Type
1223266 Journal of Pharmaceutical and Biomedical Analysis 2008 9 Pages PDF
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.

Related Topics
Physical Sciences and Engineering Chemistry Analytical Chemistry
Authors
,