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Registerpartial AUCs for locally acting MR [Design Issues]
Hi all,
Recently we have conducted a pilot BE study of Mesalamine granules 4g. Partial AUCs (AUC0-12 and AUC12-t) were one of the primary parameters as this is for EMA. In this study AUC12-t parameter was not calculated as the concentrations after 12 were BLQ for almost all subjects except one or two subjects. what would be the possible reason for this?
Some solutions suggested by experts include
1) lowering the LLOQ range 2) Increase the dosage (but don't know the highest acceptable dose in healthy volunteer studies).
Any advice and suggestions will be a great help.
Thanks in advance
Kumar
Recently we have conducted a pilot BE study of Mesalamine granules 4g. Partial AUCs (AUC0-12 and AUC12-t) were one of the primary parameters as this is for EMA. In this study AUC12-t parameter was not calculated as the concentrations after 12 were BLQ for almost all subjects except one or two subjects. what would be the possible reason for this?
Some solutions suggested by experts include
1) lowering the LLOQ range 2) Increase the dosage (but don't know the highest acceptable dose in healthy volunteer studies).
Any advice and suggestions will be a great help.
Thanks in advance
Kumar
Complete thread:
- partial AUCs for locally acting MR Susanh 2020-12-04 16:14 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- partial AUCs for locally acting MR jag009 2020-12-05 08:01
- partial AUCs for locally acting MRKumarnaidu2 2021-05-28 11:55
- partial AUCs for locally acting MR dshah 2021-05-31 08:47
- partial AUCs for locally acting MRKumarnaidu2 2021-05-28 11:55
- partial AUCs for locally acting MR jag009 2020-12-05 08:01
Ing. Helmut Schütz