Stability data is one of the critical component of dossier registration ( for API's FP's or any other formulation for human consumption) and ICH does give provision and explanation on the statistical analysis.
I would be helpful, if some educated member could elaborate the same for ease of understanding and interpretation for members with non-statistical background.
Sir , As i am a student of M.Pharm and my project work is on stability study can yu please help should i refer to understand statistical analysis of stability data.I am much intersted in this topic.Can you guide me in understandingsuch a important topic?
Definitely adding the statistical analysis section to your M.Pharm project is going to make the project COMPLETE.
There occurs many scenario during practical registration where you are required to make us of Stastistical techniques to support your claims and also to determine the impact of overages over the shelf life of the product. However a proper guidance with appropriate statistical tool need to be used and many other factors need to be considered ( eg : suitability of individual data for pooling and subsequent interpretation.........) before the actual analysis and conclusion could be arrived.
I look forward for some expert to take this forward
I do lot of statistical evaluation of stability data using Slimstat software for shelf life projections. ICH Q1E Evaluation of stability data - is very informative to start with. Please post your questions after reviewing ICH Q1E. It is an interesting and valuable topic to carry on.
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