Complicated [Design Issues]

posted by ElMaestro  – Denmark, 2010-06-07 20:28 (5015 d 03:52 ago) – Posting: # 5459
Views: 8,035

Dear ioanam,

This is a tricky situation. I would encourage you to (ask the man with the money to) seek scientific advise or whatever equivalent is available if your target market is not Europe. You have a complicated drug, complicated info on the ref SPC, and you need to tiptoe through an ethical mine field.

I agree with HS, that a parallel study in patients is likely to be the way to do it.

Best regards

Pass or fail!

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