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30th Nov 2011, 11:25 PM
#1
Re-packing of Non IMP
We are going to a run a trial which involves EU licences non IMP product. This is a double blind cross over study where we have two strengths of nonIMP and
placebo. The patient will receive strenght 1 on day 1 strenght 2 on day 2 and placebo on day 3. The researcher wants to recruit about 10 subjects and wants to
keep all the stock in their department.
Is it OK to encapsulate the IMP to keep researcher and subject blinded at Hospital site or it has to be re-pack or encapsulate on a different site which has MA.
On a pharmacy side is it OK to re-pack the tablet in a empty capsules(for double blind) and dispensed to patient by patient basis.
Many thanks in advance
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