Assessing distributions of estimated drug shelf lives in stability analysis

A stability study is usually conducted to ensure that a drug product can me et the approved specifications prior to its expiration dating period (shelf life). Several approaches for determination of drug shelf life assuming ra ndom batches have been proposed. In this paper, we examine sampling distrib utions of the estimated shelf lives proposed by Shao and Chow (1994, Biomet rics 50, 753-763). An application to some stability data from the pharmaceu tical industry is presented.