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RegisterSimilar dissolution rate but Failed BE study [Dissolution / BCS / IVIVC]
Dear all
We conducted a BE study for a BCS 2 drug, we evaluated dissolution rate of Test and R products before BE study, We thought the dissolution rate was Similar, then we conduct the study.
But the result of the study make us shocked, especially the opposite results in fasting and Fed STUDY.
The results are as follows:
![[image]](img/uploaded/image37.jpg)
I think the results are very weird, as the trendency was opposite in both studies.
Here, could you all pls give me a hand for explanation? Thanks a million!
So I Go back to have a look at the dissolution rate in vitro as follows:![[image]](img/uploaded/image38.jpg)
Here, could you all pls give me a hand for explanation? Thanks a million!
Abby
We conducted a BE study for a BCS 2 drug, we evaluated dissolution rate of Test and R products before BE study, We thought the dissolution rate was Similar, then we conduct the study.
But the result of the study make us shocked, especially the opposite results in fasting and Fed STUDY.
The results are as follows:
I think the results are very weird, as the trendency was opposite in both studies.
Here, could you all pls give me a hand for explanation? Thanks a million!
So I Go back to have a look at the dissolution rate in vitro as follows:
Here, could you all pls give me a hand for explanation? Thanks a million!
Abby
Complete thread:
- Similar dissolution rate but Failed BE studywanabby 2012-09-26 03:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS II… Helmut 2012-09-26 14:20
- Similar dissolution rate but Failed BE study jag009 2012-09-27 21:29
- Excipients Helmut 2012-09-29 14:00
- Excipients jag009 2012-10-01 22:35
- test or reference? Helmut 2012-10-02 19:58
- Excipients jag009 2012-10-01 22:35
- Excipients Helmut 2012-09-29 14:00
- Similar dissolution rate but Failed BE study ElMaestro 2012-10-01 23:06
Ing. Helmut Schütz