Assessing distributions of estimated drug shelf lives in stability analysis

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