Hello,
I have an analysis problem I'd like some advice on. Below is a table of some real stability data- from which I'm trying to extract a reasonable stability prediction.
I usually use the degradation profiler for this, and have done up until now without any issue for multiple other projects - but this dataset is causing me a headache; I believe it's because we had an anomalously low T0 which skewed the trend making the predictions….. Optimistic.
Table Linked - with the associated acceptance limits we have.
Notes:
1-This is a real-world example, so it's a fully understood system.
2-We know therefore, that it is impossible for this material to gain activity. i.e. the upward trend is due to assay noise.
3-We also know from previous data and experiments that this material degrades in a roughly linear fashion, and expiry's (i.e. when the confidence levels cross the lower limit) in the region of 730-1095 days are not unusual.


My question therefore is how to analyse this. I'd be comfortable using something like a wider confidence interval and expanding that out as the prediction but wouldn't know how to do that.
The next data collection point is in 3 months, so while I'm comfortable that the 'real' trend will emerge over time and the early assay noise will be averaged out I need to make some sort of realistic prediction now. Any suggestions/guidance (despite telling-off the scientist who did the T0
) would be great!
Jon