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Registercomparative dissolution profile between various strengths [Dissolution / BCS / IVIVC]
Dear Falisa
Without knowing the details I can only give a general statement: Surfactants should be avoided whenever possible.
If dissolution is >80% in 15 minutes you do not have to calculate and present f2 values. The formulations are regarded similar without further mathematical proof.
The batch used to perform the BE study is the base for your CDP. If you use a different batch you have to give evidence that the other batch shows the same results as the BE batch and you have to give a reasonable rationale to do so.
I hope this helps.
Kind regards
Dan
Without knowing the details I can only give a general statement: Surfactants should be avoided whenever possible.
If dissolution is >80% in 15 minutes you do not have to calculate and present f2 values. The formulations are regarded similar without further mathematical proof.
The batch used to perform the BE study is the base for your CDP. If you use a different batch you have to give evidence that the other batch shows the same results as the BE batch and you have to give a reasonable rationale to do so.
I hope this helps.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- comparative dissolution profile between various strengths Falisa_Mustafa 2010-08-09 04:34 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- comparative dissolution profile between various strengthsDr_Dan 2010-08-09 09:42
- comparative dissolution profile between various strengths Falisa_Mustafa 2010-08-20 10:31
- comparative dissolution profile between various strengthsDr_Dan 2010-08-09 09:42
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