Team,

Would anyone have any experience with conducting In-Use stability studies for an oral  liquid formulation  such as a syrup, to indicate how close to the daily dosing you have to mirror the in-use stability study.
For example if the daily dose is 2mls once per day, would it be acceptable to design the In-Use stability study to remove 14mls (1 week's supply)  aliquots from a bottle once a week.

If you are aware of any ICH guidances, or regulatory experiences etc, please let me know
Thanks
Tila Balasuriya






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