Bioequivalence and Bioavailability Forum • AUC in steady state

AUC in steady state [Design Issues]

posted by Helmut – Vienna, Austria, 2024-01-27 23:01 (869 d 03:16 ago) – Posting: # 23842
Views: 5,370

Hi Divyen,

❝ 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.

Here you err. Neither AUC_0–t nor AUC_0–∞ are PK metrics of the extent of absorption in steady state.

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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Steady state BE study dosing NK 2024-01-19 04:24 [Design Issues]
- Circadian rhythm? Helmut 2024-01-20 12:50
- Steady state BE study dosing dshah 2024-01-22 10:09
  - AUC in steady stateHelmut 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