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RegisterFailed fasting but passed fed study [Dissolution / BCS / IVIVC]
Dear Ohlbe
Regards
Sorry the drug is BCS class 1 molecule. T/R ratios for fasting pilot
(14 subjects) are Cmax (74%), AUC 0-t (81%) and AUC o-inf (89%). Intrasubject cv was <30% (23%-cmax, 20%-AUC 0-t, 21%-AUC 0-inf). In extrapolation in 60 subjects the drug was still found to be on lower side (with very slight difference from the existing study) but for fed studies we were having Cmax (97%), AUC 0-t (108%) and AUC o-inf (110%) and in extrapolation we are very comfortable.
Please suggest me some solutions........
Regards
Sorry the drug is BCS class 1 molecule. T/R ratios for fasting pilot
(14 subjects) are Cmax (74%), AUC 0-t (81%) and AUC o-inf (89%). Intrasubject cv was <30% (23%-cmax, 20%-AUC 0-t, 21%-AUC 0-inf). In extrapolation in 60 subjects the drug was still found to be on lower side (with very slight difference from the existing study) but for fed studies we were having Cmax (97%), AUC 0-t (108%) and AUC o-inf (110%) and in extrapolation we are very comfortable.
Please suggest me some solutions........
Complete thread:
- Failed fasting but passed fed study Bhupesh 2008-03-13 12:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Failed fasting but passed fed study Ohlbe 2008-03-13 15:17
- Failed fasting but passed fed studyBhupesh 2008-03-14 06:55
- Failed fasting but passed fed study Ohlbe 2008-03-13 15:17
Ing. Helmut Schütz