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RegisterFailed AUC 0-t [Study Assessment]
Dear Helmut,
116 was the ratio for Cmax.
Reformulation for an IR product is quite tricky esp if Cmax is matching. This scenario is possible for MR product for which IVIVC will give a clear picture.
How would reformulation be planned for an IR product with matching Cmax but dissimilar AUC 0-t? Can IVIVC be done for IR product?
❝ I would reformulate. BTW, what was the ratio for Cmax?
116 was the ratio for Cmax.
Reformulation for an IR product is quite tricky esp if Cmax is matching. This scenario is possible for MR product for which IVIVC will give a clear picture.
How would reformulation be planned for an IR product with matching Cmax but dissimilar AUC 0-t? Can IVIVC be done for IR product?
Complete thread:
- Failed AUC 0-t Tina 2013-08-29 09:25 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Failed AUC 0-t Dr_Dan 2013-08-29 11:04
- Failed AUC 0-t Tina 2013-08-29 13:11
- bear for replicates Helmut 2013-08-29 14:33
- Failed AUC 0-t Helmut 2013-08-29 13:58
- Failed AUC 0-tTina 2013-08-29 17:48
- Correct numbers? Helmut 2013-08-29 18:24
- Failed AUC 0-tTina 2013-08-29 17:48
- Failed AUC 0-t luvblooms 2013-08-30 09:23
- Failed AUC 0-t Dr_Dan 2013-08-29 11:04
Ing. Helmut Schütz