Is there any guideline restricting to extrapolate re-test period of API from 36 month on-wards?
I mean, as per ICH we can extend re-test period for the product storing at CRT by using below formula…
Y = 2X or Y = X+12 which is lesser in both.
I have 36 month long term [25°C/60%RH] & 6 months accelerated data [40°C/75%RH] and stability studies are on-going.
Based on this data can I assign 48 months re-test?
Is there any guideline restricting to assign 48 months re-test if i have 36 months data.