Max Bulk Hold Time without a stability study?

[John O’Neill]

#26160

Hi Cheryl,

Turns out we have a pertinent article on the topic right here in StabilityHub written by our European correspondent Piero De Filippis.: https://stabilityhub.com/2021/11/03/ema-guidance-on-stability-studies-for-bulk-product-storage-support/ He includes 5 references as examples of which Guidances do and don’t address the issue.

That said, what do our knowledgable subscribers have to say on the subject?

[Author]

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