Stein,
In general, you are advised to check the ICH stability guidelines for
the regulations around testing drug products - see Q1A,
http://www.emea.europa.eu/pdfs/human/ich/273699en.pdf. Long-term
testing is required at either 60 or 65% relative humidity. Read the
guideline. Drugs should not be stored in the fridge unless it
specifically says on the label, store in refrigerator. In any case, I
would have thought that in Norway it doesn't get all that hot, does it?
;-)
All the Best,
Pete
Peter Lassoff, Pharm.D.
Vice President, Europe
PAREXEL Consulting
Email: Peter.Lassoff@parexel.com
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