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RegisterSteady state BE study dosing [Design Issues]
Dear All,
We are planning a steady state bioequivalence study on healthy subject with tid dosing (every 8 hours) on day 1 to day 4. Serial PK blood sample collections are planned on Day 5 after morning dosing(expected to reach steady state concentration on day 5).
Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours?
Thanks in advance!
Regards
NK
Edit: Category changed; see also this post #1. [Helmut]
We are planning a steady state bioequivalence study on healthy subject with tid dosing (every 8 hours) on day 1 to day 4. Serial PK blood sample collections are planned on Day 5 after morning dosing(expected to reach steady state concentration on day 5).
Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours?
Thanks in advance!
Regards
NK
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Steady state BE study dosingNK 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 dosing dshah 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