Stability study duration

Stability
1

Is there any scientific reason for carrying out accelerated stability studies for 6 months. Is it possible to extend it from 6 months.

2

Yaaa Possible, As per ICH GUIDELINES Q1 Said ACC Performed Minimum 6 months.
Maximum Not mention Anywhere.

3

Yes you can continue stability for “n” number months. FDA’s requires 06 months of accelerated stability data at the time filing.

4

Thanks for your response @Samba_Siva_Reddy

5

Thanks for your response @ndinesh624