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18th Sep 2012, 08:57 PM
#1
IMP -using a licenses product in a new population group
Hi
Could someone tell me where to find some guidance relating to performing a study with a drug that is licensed in the UK but may or may not be licensed in a particular patient group. This product is used widely in hospitals and would be standard care, do we need to manufacture the IMP etc?
Im just trying to think of the logistics pertaining to this
Thanks
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