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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References
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Acknowledgements
The authors gratefully acknowledge the Product Quality Research Institute and the members of the PQRI Stability Shelf Life Working Group (SSL WG). The authors had the privilege of serving as active members of the PQRI SSL WG from its inception through 2010, and have continued their association with the working group from 2010 to the present. Citations by Capen, Christopher, Quinlan, Stroup and Schwenke all represent PQRI SSL WG efforts. The working group continues its efforts to understand current shelf life estimation practice and investigate alternative methodology with the potential to improve existing practice. Without our time as members of the working group, this chapter would not be possible. We also acknowledge Stan Altan. His review, suggestions and overall support are much appreciated.
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Stroup, W.W., Quinlan, M. (2016). Statistical Considerations for Stability and the Estimation of Shelf Life. In: Zhang, L. (eds) Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-23558-5_22
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DOI: https://doi.org/10.1007/978-3-319-23558-5_22
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