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RegisterSimilar dissolution rate but Failed BE study [Dissolution / BCS / IVIVC]
Hello wanabby,
interesting.
I shall not volunteer any suggestions at this time, but could you comment on the following:
interesting.
I shall not volunteer any suggestions at this time, but could you comment on the following:
- Which API?
- Was the fed and fasted investigation a single study (i.e. both fed and fasted in the same study, same subjects, same protocol), or were the two conditions separate in time and possibly space (CRO)?
- Were the same batches of T and R used for fasted and fed?
- Can you show the LSMeans for T and R, fasted as well as fed?
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Similar dissolution rate but Failed BE study wanabby 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 studyElMaestro 2012-10-01 23:06
Ing. Helmut Schütz