Robustness is the capacity of a method to remain unaffected by small, deliberate variations in method parameters; a meas- ure of the reliability of a method. Robustness should be evaluated in late development, or early in the method validation process. ... Robustness can be used to establish system suitability parameters.

What is method robustness?

One of the most widely used definitions for method robustness in pharma is given by ICH: 'The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage'.

What are robustness studies?

In statistics, the term robust or robustness refers to the strength of a statistical model, tests, and procedures according to the specific conditions of the statistical analysis a study hopes to achieve. ... In other words, a robust statistic is resistant to errors in the results.