Shelf-life estimation of pharmaceutical products by matrixing
Yoshioka, S.; Aso, Y.; Kojima, S.
Eisei Shikenjo Hokoku. Bulletin of National Institute of Hygienic Sciences 114: 143-144
1996
ISSN/ISBN: 0077-4715 PMID: 9037887 Document Number: 455774
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.