It helps to have some experience with regulators on this. Linear extrapolation of stability data has been done for years. While that may not make it "right", there is an impressive track record. The problem with shifting to any of the time series methods is that the number of time points on these studies is often too small to be able to estimate the parameters, the time points are not equally spaced, and the measurements are not on the same sample (i.e., several samples are taken at the initiation of the stability testing period, and then destructively analyzed at pre-determined time points). Consequently, a lot of time series methods aren't robust enough to deal with this.
As far as survival analysis, I think you would need multiple samples to analyze at each pre-determined time point to be able to estimate the hazard ratio (failure rate). Unless the synthesis has been scaled up to a near production level, there may not be sufficient test article to carry out a decent survival analysis.
So for once, I can understand the use of a not-quite-right method.
SteveDenham
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