Use of Statistics to Establish a Stability Trend: Matrixing
Guidance Q1E gives several options for calculating shelf life. These options are compared using examples. Bracketing and matrixing (Guidance Q1D) are the ways to reduce the amount of testing in a stability study. Examples of matrixed and bracketed designs are presented, and the probabilities of obtaining a given shelf life for the reduced designs are compared to the same probabilities for the full design.