Example data loaded: three registration batches, 0 to 18 months.
The report includes study design, a results table, the poolability tests, the regression chart, the shelf-life conclusion and blank sign-off lines for your reviewer and approver.
Method: least-squares regression per batch; batch poolability tested by ANCOVA at the 0.25 significance level (slopes first, then intercepts); shelf life is where the one-sided 95% confidence bound of the mean (two-sided for two limits) meets the acceptance criterion. Proposed shelf life is capped at twice the data period and no more than 12 months beyond it, as ICH Q1E allows when supported by accelerated data. This is a draft for review by a qualified person.