[Shelf-life estimation of pharmaceutical products by matrixing].

Abstract

The shelf-life estimates of pharmaceutical products obtained by matrixing are compared with those obtained by ordinary analysis, using stability data generated by the Monte Carlo method. The effect of the variation in stability due to different packaging and formulations on the shelf-life estimates is described. Analysis of variance is proposed for the evaluation of shelf-life estimates obtained by matrixing. The relationship between the power of the test and the significance level is discussed as well as the effect of assay error on the power of test.