Xy. Su et al., PREDICTING SHELF-LIVES OF PHARMACEUTICAL PRODUCTS - MONTE-CARLO SIMULATION USING THE SIMULATION PACKAGE SIMAN, Journal of thermal analysis, 41(2-3), 1994, pp. 713-724
The computer simulation package SIMAN(R) is used to carry out Monte Ca
rlo simulations with a view to estimating and predicting the shelf-liv
es of pharmaceutical products. The input data take account of assay va
riance and low extents of decomposition typical of data sets submitted
by pharmaceutical companies in support of their product licence appli
cations. It is shown that Monte Carlo methods provide estimates of the
predicted shelf-life with a narrower and more symmetrical distributio
n than obtainable with integral methods. The results indicate that the
median may be a more reliable estimate of shelf-life than the mean pa
rticularly if assay variance is high. Despite its usefulness SIMAN is
a difficult package to use and is not generally recommended.