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RegisterFailed fasting but passed fed study [Dissolution / BCS / IVIVC]
Dear Friends
Regards
We are working on a BCS class two molecule which is enteric coated. We are getting very good results in Fed pilot study but getting lower T/R% ratios in Fasting study. We checked release in ph 1.2, 2.98 and 4.5 buffer, the drug is not getting released in these media and this is shown in the biostudy also where we are getting a lag time of 1-3 hr.
What may be the reason of this failure in fasting biostudy and how to solve it?
Thanks a lot.............
Regards
We are working on a BCS class two molecule which is enteric coated. We are getting very good results in Fed pilot study but getting lower T/R% ratios in Fasting study. We checked release in ph 1.2, 2.98 and 4.5 buffer, the drug is not getting released in these media and this is shown in the biostudy also where we are getting a lag time of 1-3 hr.
What may be the reason of this failure in fasting biostudy and how to solve it?
Thanks a lot.............
Complete thread:
- Failed fasting but passed fed studyBhupesh 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 study Bhupesh 2008-03-14 06:55
- Failed fasting but passed fed study Ohlbe 2008-03-13 15:17
Ing. Helmut Schütz