How to perform the repeatability of analytical method validation?

刊登日期:2019-11-22  |  點閱次數 : 1669 次 

For the repeatability of analytical method validation, it should be tested by at least six replications measured at 100 percent of the test target concentration or by at least nine replications covering the complete specified range. For example, the results can be obtained at three concentrations with three injections at each concentration. Please refer to ICH Q2 requirements for repeatability of precision.



上一筆 Is endotoxin testing considered an essential part of shelf-life specification to
下一筆 One identification test method of current drug product specification is to compar