Bioequivalence and Bioavailability Forum

Achievement of Steady State: Visual inspection & common sense [General Sta­tis­tics]

posted by Ben – 2021-08-05 08:08 (124 d 12:19 ago) – Posting: # 22509
Views: 1,527

Hi Helmut,

» Run a linear regression of pre-dose concentrations vs time and test the slope against zero (or whether zero is included in the 95% CI of the slope). The former should be part of the output.
» However, I don’t recommend it (see there).

So you are essentially saying statistical relevance is not the right tool here. Agreed. Instead of relying on visual inspection & gut feeling (= common sense? ) can we define pharmacological relevance? Is there a way to define quantitative thresholds based on the PK (or even PD?) of the compound (i.e. concentration should not change by more than x%)?

Best regards,
Ben.

Complete thread:

• Achievement of Steady State arl_stat 2021-07-31 07:42 [General Sta­tis­tics] 
  • Achievement of Steady State: Visual inspection & common sense Helmut 2021-07-31 10:58
    • Achievement of Steady State: Visual inspection & common senseBen 2021-08-05 08:08
      • Threshold of % change? Helmut 2021-08-05 11:43
        • Threshold of % change? Ben 2021-10-17 12:16
          • Keep it simple Helmut 2021-10-20 12:36