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RegisterWhat if F2 is ok but F1 isn't ? [Dissolution / BCS / IVIVC]
Hi Mr.Helmet,
We have regulations in our country to perform a comparative dissolution test before bioequivalence and in these results I face this problem mainly in the actives with low solubility and low release profile without surfactant.
What could be done in this case ?
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
We have regulations in our country to perform a comparative dissolution test before bioequivalence and in these results I face this problem mainly in the actives with low solubility and low release profile without surfactant.
What could be done in this case ?
❝ What’s your purpose of comparing f1? Product development? For BCS-based biowaivers and proportionality waivers (different strengths) you need only f2.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- What if F2 is ok but F1 isn't ? Amira 2014-12-10 15:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- What if F2 is ok but F1 isn't ? Helmut 2014-12-10 15:56
- What if F2 is ok but F1 isn't ?Amira 2015-02-17 19:16
- In vivo overrules in vitro Helmut 2015-02-18 13:23
- What if F2 is ok but F1 isn't ?Amira 2015-02-17 19:16
- What if F2 is ok but F1 isn't ? Helmut 2014-12-10 15:56
Ing. Helmut Schütz