Biowaiver of strengh in fixed combinatios [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-05-18 16:38 (3555 d 09:50 ago) – Posting: # 14849
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Hi Averroes and Dr_Dan,

❝ Could anybody, as per your experience, let me know how EMA regulatory authorities interprete this?


It is a situation that is not covered by the guideline. And as such I am not sure there is one solution that is guaranteed to work with a high probability across man agencies.
Therefore, get scientific advice and apply lots of common sense in the briefing document. I know the issue of common sense is subject to much debate and confusion but in this regard I think it should imply scientifically balanced views and not just quick and cheap approval.:-D

Pass or fail!
ElMaestro

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