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John O’Neill
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Post count: 77

The particular accelerated condition would depend on the nature of the product; if solid oral, 40C/75% is common, if refrigerated or frozen product, then 25C, 30 C, or even refrigerated can be considered accelerated conditions relative to the standard storage condition.

I’m not aware of any open-tray guidances or requirements, but that said, I would go with your standard (as in packaged product) accelerated conditions protocol, but if budget allows, add an interval or two in the first quarter of the accelerated study to determine if there is an early impact from lack of packaging. That could yield a more accurate idea of open-tray shelf life vs the packaged shelf life.

How about the rest of you who do open dish studies at accelerated conditions? What practices do you follow?