Dear All,
I check the below link for stability extrapolation based on ICH Q1E
https://www.jmp.com/support/help/en/17.0/index.shtml#page/jmp/stability-analysis-in-the-degradation-platform.shtml#
But, I have a concern for it. This example is for one measurement for each time point. However, pharmaceutical tests for instance assay analysis, we perform more than 1 measurement for each time point. Generally 3 measurements or based on investigation more than 3 will be performed. So, I would like to ask if we have multiple results for different timepoints, how can we perform extrapolation of them? do we need to calculate mean of each time point for extrapolation or can we use each individual results to calculate expiration time point.
Could someone clarify for it?
