ABSTRACT
These terms are referred to as "analytical perform ance parameters" or sometimes as "analytical figures of merit/' Most of these terms are familiar and are used daily in the laboratory. However, some may mean dif ferent things to different people. To avoid confusion, therefore, it is necessary to have a complete understand ing of the terminology and definitions. Recognizing this, one of the first harmonization projects taken up by the ICH was the development of the guideline "Validation of Analytical Methods: Definitions and Terminology." ICH divided the validation characteristics somewhat differ ently, as outlined in Figure 4.
