Pharmaceutical Statistics Using SAS

4.9. Summary

Throughout this chapter we have proposed ways to understand, estimate and interpret various criteria required for assessing the validity of an analytical method. These criteria must be reported and the code used to compute the criteria must be documented according to best practices. Regardless of the complexity of computations and models, the objective of an analytical method (are the measurement errors acceptable?) should never be forgotten and should remain the primary focus. The information needed to make a decision is contained in the measurement error profile. All performance criteria—linearity, accuracy, precision, limits, measurement errors—can be assessed using a graphical profile and can be easily understood and interpreted ...