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RegisterBE studies with Apple sauce [Study Performance]
Hi,
Is it possible to fail a BE study on applesauce give that the fasting BE (non-applesauce) study is perfectly bioequivalent. The drug has intrasubject CV in the 15-20% range, not HVD. The 90% CI has a upper limit of 120% (still less than 125). Fed study is BE was well.
I mean if everything goes well, no dropping of capsule content, subject swallowed all the apple sauce + drug content.
Just curious if the capsule shell itself would have an effect.
Thanks
John
Is it possible to fail a BE study on applesauce give that the fasting BE (non-applesauce) study is perfectly bioequivalent. The drug has intrasubject CV in the 15-20% range, not HVD. The 90% CI has a upper limit of 120% (still less than 125). Fed study is BE was well.
I mean if everything goes well, no dropping of capsule content, subject swallowed all the apple sauce + drug content.
Just curious if the capsule shell itself would have an effect.
Thanks
John
Complete thread:
- BE studies with Apple saucejag009 2012-07-10 17:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE studies with Apple sauce Helmut 2012-07-10 18:07
- BE studies with Apple sauce jag009 2012-07-10 20:15
- BE studies with Apple sauce Helmut 2012-07-10 18:07
Ing. Helmut Schütz