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] 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

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1593 1599 International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: Harmonised Triplicate Guideline on Validation of

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References [1] S. Sweetman (ed.), Martindale: The Complete Drug Reference , 35 th edn., Pharmaceutical Press , London

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. ICH Guidance on Analytical Method Validation, In: Proceedings of the International Convention on Quality for the Pharmaceutical Industry, Toronto, September 2002.

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Rosuvastatin calcium drug review from rx list www.rxlist.com/generic/rosuvastatin calcium.htm K. Parfitt (Ed.) Martindale — The Complete Drug Reference, Pharmaceutical

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Acta Chromatographica
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

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1566 1576 ICH Guidance on Analytical Method Validation. In: Proceedings of the International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September 2002

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Journal of Thermal Analysis and Calorimetry
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

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-Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations, 2nd edn., CBS Publishers and Distributors, New Delhi, 1996. Sethi P.D. High-Performance Thin

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Predicting shelf-lives of pharmaceutical products

Monte Carlo simulation using the simulation package SIMAN

Journal of Thermal Analysis and Calorimetry
Authors: X. Su, A. Wan Po, and S. Yoshioka

Abstract  

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.

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