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RegisterBracketing approach for multiple strenght product EMA [Regulatives / Guidelines]
Dear J!
If the dissolution is more than 85% in 15 min, then F2 would not be applicable. However, for multimedia dissolution for a BCS class II drug, there is a high possibility that in at least one media, the dissolution would be slower and thus F2 can be applied.
Regards,
Dshah
If the dissolution is more than 85% in 15 min, then F2 would not be applicable. However, for multimedia dissolution for a BCS class II drug, there is a high possibility that in at least one media, the dissolution would be slower and thus F2 can be applied.
Regards,
Dshah
Complete thread:
- Bracketing approach for multiple strenght product EMA jag009 2021-07-06 19:19 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bracketing approach for multiple strenght product EMAdshah 2021-07-17 11:44
Ing. Helmut Schütz