Biowaiver of strengh in fixed combinatios [Regulatives / Guidelines]
Hi Averroes and Dr_Dan,
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.
❝ 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.

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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Biowaiver of strengh in fixed combinatios Averroes 2012-01-18 13:05 [Regulatives / Guidelines]
- Biowaiver of strengh in fixed combinatios Dr_Dan 2015-05-18 10:21
- Biowaiver of strengh in fixed combinatiosElMaestro 2015-05-18 14:38
- Biowaiver of strengh in fixed combinatios Dr_Dan 2015-05-18 10:21