Abstract
A graphical plot of drug stability-study data can be extrapolated to estimate the drug’s percent degradation and therefore its shelf-life beyond the time period of the study. However, after a statistical confidence limit is applied, that shelf-life estimate is significantly reduced. Such a reduction can be minimized by transforming the data so that it plots as close as possible to linearity, a process that is called reliability plotting. Reliability plotting seems to have been rarely if ever used on drug stability data, despite its being mentioned in relevant guidance documents and its ability to justify longer shelf-life at no additional cost. For example, an 18-month stability study resulted in a 19-month shelf-life using standard extrapolation methods but resulted in a 23 month shelf-life using reliability plotting.
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