Significance Levels For Stability Pooling Test: A Simulation Study

Shelf life of a drug product is defined as the length of time under specific conditions of storage that the product will remain within specifications established to ensure its identity, strength, quality, and purity. The objective of an new drug application (NDA) stability study is to collect and evaluate the evidence in support of the sponsor-proposed shelf life. The proposed shelf life is supported when each batch of the drug products in the study has shelf life no shorter than the proposed shelf life. When the value of the batch mean changes linearly, sometimes batches of the same product may share the same slope or regression line. In practice, batches are pooled to have a common estimate of slope or regression line when there is no significant difference in slope or regression line. Such practice is often applied in pooling across levels of a design factor such as package or strength in a stability study designed with multiple factors. However, falsely pooling different slopes or intercepts may incre...