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RegisterWaiver of lower strength [Regulatives / Guidelines]
Dear All,
Thanks for this great forum. I learn a lot from it!!
As per EMA guideline (Section 4.1.6), proportionality in composition is still fulfilled if the amount of the active substance is less than 5% of the tablet core weight in both the strength used in the BE study and the strength for which a waiver is considered.
My question is simple: the weight of the active substance (salt) is more than 5% in the higher strength, but if we consider the base, it is less than 5% in both formulations.
Which is considered by EU Regulators the active substance for calculations, salt or base?
Can we expect a waiver for lower strength taking into account we meet the criteria for the base?
Thanks in advance!!!
Thanks for this great forum. I learn a lot from it!!
As per EMA guideline (Section 4.1.6), proportionality in composition is still fulfilled if the amount of the active substance is less than 5% of the tablet core weight in both the strength used in the BE study and the strength for which a waiver is considered.
My question is simple: the weight of the active substance (salt) is more than 5% in the higher strength, but if we consider the base, it is less than 5% in both formulations.
Which is considered by EU Regulators the active substance for calculations, salt or base?
Can we expect a waiver for lower strength taking into account we meet the criteria for the base?
Thanks in advance!!!
Complete thread:
- Waiver of lower strengthAverroes 2011-10-20 14:45 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Waiver of lower strength JMCardot 2011-10-24 12:02
- Waiver of lower strength Averroes 2011-10-24 17:18
- Waiver of lower strength JMCardot 2011-10-24 12:02
Ing. Helmut Schütz