International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use , Guideline on Validation of Analytical Procedures: Methodology , adopted in 1996 , Geneva
Authors:Muhammad Hanif, Shahid Shah, Nasir Rasool, Ghulam Abbas, Malik Saadullah, Sajid Mehmood Khan, Muhammad Masood Ahmed, Nazar Abbas, Mehran Ashfaq, and Omeira Iqbal
Introduction Nowadays, polysaccharide based advanced and innovative pharmaceutical materials are preferred because of their natural abundance, easy accessibility, low cost, biodegradability, nontoxicity and furthermore, their sustainable nature has
Authors:Lakshmi Kaza, Hany F. Sobhi, Jeffrey A. Fruscella, Chris Kaul, Shravan Thakur, Naullage I. Perera, Kenneth Alexander, and Alan T. Riga
following is a summary from W.J. Sichina's paper “Characterization of Water of Hydration of Pharmaceuticals Using the DSC”, in which a test was developed to characterize the properties associated with the water in a pharmaceutical material. The method
The computer simulation package SIMAN® is used to carry out Monte Carlo simulations with a view to estimating and predicting the shelf-lives of pharmaceutical products.
The input data take account of assay variance and low extents of decomposition typical of data sets submitted by pharmaceutical
companies in support of their product licence applications. It is shown that Monte Carlo methods provide estimates of the
predicted shelf-life with a narrower and more symmetrical distribution than obtainable with integral methods. The results
indicate that the median may be a more reliable estimate of shelf-life than the mean particularly if assay variance is high.
Despite its usefulness SIMAN is a difficult package to use and is not generally recommended.