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Dear Members,
one of our sponsors have requested to conduct a bioequivalence study
of carbamazepine XR 400mg OD Vs 200 mg BD.
can you please help me in planning the study.
regards,
kiran
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The following message was posted to: PharmPK
Dear Kiran
You can plan two way cross over single dose oral bioavailability
study under fasting and fed conditions. OD would be dosed once a
day, while BD would be dosed twice a day [one in the morning and one
in the evening at the interval of 12 hr]. In which, bioequivalence
would on the basis of 90% CI for AUC0-t and / or AUC0-inf, not on the
Cmax.
Rest other things would reamin same like normal BA BE studies.
Hope this would suffice your purpose.
Group can alway correct me, if I am wrong or additions to this is
appreciated.
- Mitesh Gandhi -
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