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RegisterSteady state BE study dosing [Design Issues]
Hi NK!
So you are asking for protocol preparation consideration. The study is in healthy volunteers- so I believe that AUC0-t/AUC0-inf>=0.8 also needs to be followed, so consider sampling accordingly.
Regards,
Divyen
❝ Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours?
So you are asking for protocol preparation consideration. The study is in healthy volunteers- so I believe that AUC0-t/AUC0-inf>=0.8 also needs to be followed, so consider sampling accordingly.
Regards,
Divyen
Complete thread:
- Steady state BE study dosing NK 2024-01-19 04:24 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Circadian rhythm? Helmut 2024-01-20 12:50
- Steady state BE study dosingdshah 2024-01-22 10:09
- AUC in steady state Helmut 2024-01-27 22:01
- AUC in steady state dshah 2024-01-27 22:06
- AUC in steady state Helmut 2024-01-27 22:16
- AUC in steady state dshah 2024-01-27 22:06
- AUC in steady state Helmut 2024-01-27 22:01
Ing. Helmut Schütz