in vivo data before tweaking in vitro [Dissolution / BCS / IVIVC]
Hi Kiran,
a generic product must demonstrate BE in the rate (Cmax) and extent of absorption (AUC), right?
If your dissolution method is not predictive (you can’t tell before you have in vivo data!) any difference might – or might not – be relevant.
Run a small pilot study to get an idea. IMHO, it is a waste of time to first tweak the dissolution which possibly was overdiscriminatory.
a generic product must demonstrate BE in the rate (Cmax) and extent of absorption (AUC), right?
If your dissolution method is not predictive (you can’t tell before you have in vivo data!) any difference might – or might not – be relevant.
Run a small pilot study to get an idea. IMHO, it is a waste of time to first tweak the dissolution which possibly was overdiscriminatory.
—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Dissolution profie matching Kiran 2017-06-24 18:25 [Dissolution / BCS / IVIVC]
- in vivo data before tweaking in vitroHelmut 2017-06-24 19:30
- in vivo data before tweaking in vitro Kiran 2017-06-24 20:19
- locally acting / diss. similarity mandatory Helmut 2017-06-25 12:48
- locally acting / diss. similarity mandatory Kiran 2017-06-25 16:40
- locally acting / diss. similarity mandatory Helmut 2017-06-25 12:48
- in vivo data before tweaking in vitro Kiran 2017-06-24 20:19
- Dissolution profie matching ElMaestro 2017-06-25 20:21
- Dissolution profie matching Kiran 2017-06-26 05:11
- in vivo data before tweaking in vitroHelmut 2017-06-24 19:30