Use of Matrix Designs in Stability Studies: A Simulation Study

Abstract

A stability study is designed to study the degradation profile of a drug product over time. It is required that at least three batches of the drug product in its finished form be studied over time. Often it is desired to manufacture the product in various forms, using a variety of packaging options. If three batches of product are studied for each combination of these experimental conditions at each of the recommended sampling times, the cost of the study can be substantial. Simulation studies are used to examine the effect of matrix designs; it is shown that the performance of these reduced testing plans is similar to the full sampling plan in terms of power to detect slope differences and estimation of the expiration dating period.