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RegisterBiowaiver of strengh in fixed combinatios [Regulatives / Guidelines]
Dear All,
I would like to follow up Averroe's post regarding the fulfillment of proportional composition condition for a generic fixed combination in order to biowaive the lower strenght(s). If you only change the amount of one drug and the other remains the same (10/20, 20/20, 40/20) the conditions regarding proportional composition cannot be fulfilled for all active substances of fixed combinations. If you consider the drug with the fixed strength (active substance is less than 5%)as an excipient it could be interpreted that proportional composition condition is fulfilled.
Could anybody, as per your experience, let me know how EMA regulatory authorities interprete this?
Kind regards and thanks in advance,
Dr_Dan
I would like to follow up Averroe's post regarding the fulfillment of proportional composition condition for a generic fixed combination in order to biowaive the lower strenght(s). If you only change the amount of one drug and the other remains the same (10/20, 20/20, 40/20) the conditions regarding proportional composition cannot be fulfilled for all active substances of fixed combinations. If you consider the drug with the fixed strength (active substance is less than 5%)as an excipient it could be interpreted that proportional composition condition is fulfilled.
Could anybody, as per your experience, let me know how EMA regulatory authorities interprete this?
Kind regards and thanks in advance,
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Biowaiver of strengh in fixed combinatios Averroes 2012-01-18 13:05
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver of strengh in fixed combinatiosDr_Dan 2015-05-18 10:21
- Biowaiver of strengh in fixed combinatios ElMaestro 2015-05-18 14:38
- Biowaiver of strengh in fixed combinatiosDr_Dan 2015-05-18 10:21
Ing. Helmut Schütz