Bioequivalence and Bioavailability Forum

PowerTOST for steady state [🇷 for BE/BA]

posted by d_labes  – Berlin, Germany, 2016-04-07 12:54 (2934 d 10:01 ago) – Posting: # 16168
Views: 8,413

Dear BE-proff,

❝ Is it possible to calculate number of subjects for steady state study with PowerTOST?

Of course, it's the Gold Standard !

❝ What parameters are required?

The same as for sample size estimation for other types of BE studies.

• An educated guess of the variability of your primary targets (usually AUC_tau and C_max,ss in case of steady state studies)
• target power (>=80% usually), alpha (0.05 usually)
• 'True' GMR for which power should be calculated (usually set to 0.95 if no other information is available)
• design of the study

Thats all. More arguments of the sample size estimation functions in PowerTOST you may find in the man pages. These are more or less only for special purposes.

Complete thread:

• PowerTOST for steady state BE-proff 2016-04-06 21:39 
  • PowerTOST for steady stated_labes 2016-04-07 10:54
    • PowerTOST for steady state BE-proff 2016-04-07 15:42
      • RTFM Helmut 2016-04-07 16:09
        • RTFM BE-proff 2016-04-09 20:15
          • RTFM‼ Helmut 2016-04-10 00:50
            • RTFM‼ BE-proff 2016-04-10 13:42
              • RTFM‼ Helmut 2016-04-10 13:48
                • RTFM‼ BE-proff 2016-04-12 13:36