Abstract
Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval. Stability testing involves many disciplines. Huynh-Ba (Handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices. Springer, New York, 2009) presents a comprehensive survey of these various aspects. This chapter will focus on aspects that involve statistical science: specifically, the probability distribution, modeling, and estimation of shelf life. Capen et al. (On the shelf life of pharmaceutical products. AAPS PharmSciTech 13:3, 2012) and Quinlan et al. (On the distribution of batch shelf lives. J Biopharm Stat 23(4): 897–920, 2013a) gave a framework for characterizing shelf life distribution which is reviewed in the chapter. Quinlan et al. (Evaluating the performance of the ICH guidelines for shelf life estimation. J Biopharm Stat 23(4), 881–896, 2013b) investigated the consequences of currently mandated shelf life estimation procedures and proposed alternatives. These are reviewed and expanded upon in this chapter.
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