PowerTOST for steady state [🇷 for BE/BA]
Dear BE-proff,
Of course, it's the Gold Standard
!
The same as for sample size estimation for other types of BE studies.
❝ 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 AUCtau and Cmax,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
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- PowerTOST for steady state BE-proff 2016-04-06 21:39 [🇷 for BE/BA]