Dear all,
Firstly I would like to thank you for this fantastic forum.
I was wondering if any of you has any experience with extension of a stability study (for an API).
The norm for ICH is to test up to 5years, which means that protocols for these studies foresee enough samples to be stored (under suitable conditions) for 5 years.
However, if for some reason a manufacturer decides to extend this study after 5 years there would be of course no samples left to perform testing.
My question is: Is there a way to incorporate this description in a protocol, so that enough sample can be stored to be tested after 5 years and avoid deviating from the protocol?
I am looking forward to your answers.
Firstly I would like to thank you for this fantastic forum.
I was wondering if any of you has any experience with extension of a stability study (for an API).
The norm for ICH is to test up to 5years, which means that protocols for these studies foresee enough samples to be stored (under suitable conditions) for 5 years.
However, if for some reason a manufacturer decides to extend this study after 5 years there would be of course no samples left to perform testing.
My question is: Is there a way to incorporate this description in a protocol, so that enough sample can be stored to be tested after 5 years and avoid deviating from the protocol?
I am looking forward to your answers.