Statistical Analysis of Stability of Repacked Pharmaceutical Products

Abstract

Packaging/repackaging is essential to ensure pharmaceutical product’s stability (i.e. efficacy and safety). Before processing to package/repackage products into container/closures, there must be evidence to verify its stability. The most common verification methods are real-time study and statistical analysis. Real-time study can be very accurate, but it is also timeconsuming, which is inadequate for industry use. On the other hand, statistical analysis is appropriate for industry use since it can take short-term data and obtain the results quickly. In particular, we apply regression analysis on pharmaceutical product container/closure data along its decision-making framework to determine a container height 95% confidence interval and estimate the shelf life. Using a freeware program R, we are able to conduct the analysis more quickly and efficiently.