I’m currently running a stability study for an IMP and have just completed the 3 month time point, with no significant change at either long term (25 C/60 %RH) or accelerated condition (40 C/75 %RH). Under EMA IMPD guidance a shelf life of 12 months can be assigned based on positive 3 month accelerated data.
My question is on how to apply ICH Q1E shelf life. The first point of the decision tree is whether there has been a significant change at accelerated within 6 months, but we haven’t yet reached 6 month testing. Can any extrapolation be performed at this time point based on this study’s data only?