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RegisterBracketing approach for multiple strenght product EMA [Regulatives / Guidelines]
Hi all,
For drug product which have multiple strengths (lets say 3), my thinking is to run a BE study comparing highest and lowest strength, and present dissolution similarities between the three strengths + a formulation composition table showing that the formulations are proportional.
Question: What if the product release > 85% within 15 mins? If so then one can't use dissolution to demonstrate similarity.
The product is BCS class 2.
Thx
J
For drug product which have multiple strengths (lets say 3), my thinking is to run a BE study comparing highest and lowest strength, and present dissolution similarities between the three strengths + a formulation composition table showing that the formulations are proportional.
Question: What if the product release > 85% within 15 mins? If so then one can't use dissolution to demonstrate similarity.
The product is BCS class 2.
Thx
J
Complete thread:
- Bracketing approach for multiple strenght product EMAjag009 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 EMA dshah 2021-07-17 11:44
Ing. Helmut Schütz