Thanks for the light reading this morning. Wow that is obviously guidance written by committee.
"The purpose of a stability study is to establish, based
on testing a minimum of three batches of the drug substance or product, a retest
period or shelf life and label storage instructions applicable to all future batches
manufactured and packaged under similar circumstances".
Where did 3 come from? 3 batches is representative of all batches...in what world?
As you note, the use of the word stability is confusing to me and not defined in the document. It appears to be directed towards the deterioration of the drug efficacy?
I like this section:
"Data not amenable to statistical analysis"
In any case, to the OP, if you are following this guidance, month should be the covariate and you should use sequential tests on the covariate, then partial SS (type 3) for the remaining factors in your study.
"All models are wrong, some are useful" G.E.P. Box