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RegisterIssue of Alcohol Dose dumping [Regulatives / Guidelines]
Dear all,
Good morning!
We are developing XR generic formulation (market US). Our formulation is bioequivalent as well as F2 value is matching in all the required dissolution mediums.
The problem is we are failing in alcohol dose dumping study in 0.1 N HCl. what is the way out in this situation? wether regulatory (US FDA) will accept the dossier. Any justification can be provided?
Further i read the following thread
I get to understand EU's thinking but still confused about FDA's thinking. product developed is not opioid in this case.
In our case F2 value is not matching few other statistical methods for dissolution calculation shows similarity. based on this can i give justification? or else reformulation is the only way out? We used eudragit and Innovator has used HPMC polymer.
Thank you in anticipation!
Regards
Chiku:)
Copypasted last two paragraphs from a follow-up post. You can edit your own posts for 24 hours; no need to post a new one. [Helmut]
Good morning!
We are developing XR generic formulation (market US). Our formulation is bioequivalent as well as F2 value is matching in all the required dissolution mediums.
The problem is we are failing in alcohol dose dumping study in 0.1 N HCl. what is the way out in this situation? wether regulatory (US FDA) will accept the dossier. Any justification can be provided?
Further i read the following thread
I get to understand EU's thinking but still confused about FDA's thinking. product developed is not opioid in this case.
In our case F2 value is not matching few other statistical methods for dissolution calculation shows similarity. based on this can i give justification? or else reformulation is the only way out? We used eudragit and Innovator has used HPMC polymer.
Thank you in anticipation!
Regards
Chiku:)
Copypasted last two paragraphs from a follow-up post. You can edit your own posts for 24 hours; no need to post a new one. [Helmut]
Complete thread:
- Issue of Alcohol Dose dumpingChiku 2012-01-11 08:10 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Alcohol induced dose dumping (in vitro, FDA) Helmut 2012-01-11 15:44
- Alcohol induced dose dumping (in vitro, FDA) Chiku 2012-01-12 05:24
- Alcohol induced dose dumping (in vitro, FDA) Helmut 2012-01-12 16:50
- Alcohol induced dose dumping (in vitro, FDA) Chiku 2012-01-12 05:24
- Alcohol induced dose dumping (in vitro, FDA) Helmut 2012-01-11 15:44
Ing. Helmut Schütz