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Stability Analysis Calculation QuestionA customer has a question about the Stability Platform in JMP. In the cross-check of the fit model and the stability platform, he noticed that different expiry dates are calculated, especially for the different intercept and different slope models. This is also briefly described in the video (Stability Analysis - JMP for Pharmacy - Dr Byron). Apparently the stability platform uses unpooled MSE for the batches and fit model uses the pooled MSE. So far so good. However, the FDA recommends in Q 1 E Evaluation of Stability Data (europa.eu) (B.2.2.1): The retest periods or shelf lives for individual batches in the stability study can be estimated by applying the approach described in Section B. 1 using individual intercepts and individual slopes and the pooled mean square error calculated from all batches.
So his question would be, why does the stability platform use a different calculation method here than specified in the guideline? He didn't really find anything about this in the community, only that JMP refers to a calculation method according to Chow (see also Solved: Question about Stability Analysis (ANCOVA) and the pooled MSE - JMP User Community in the question) and that's the difference is apparently known about the guideline (see also Assumptions of JMP Stability Test - JMP User Community , last post).
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