Requirement of temperature data before dosing [Study Per­for­mance]

posted by Ohlbe – France, 2017-07-20 09:57  – Posting: # 17568
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Dear Anky,

What are the recommendation for storage of the IMP ?

If the product is to be kept refrigerated or frozen: yes, this is a problem, and I would not dose the subjects without temperature data.

If not: it depends on the recommendations (below 25°C, below 30°C, or nothing ?), on the stability data that the sponsor has on file (40°C / 70 % HR: e.g. if stable for 3 months but not 6, that's still OK; if unstable after 1 month, could be problematic) and on the duration of shipment.

Regards
Ohlbe

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