## Of historic(al) interest only [Power / Sample Size]

» […] You have already an SOP without references – what does it say? How do you estimate a sample size right now?

we have not yet finalized the SOP, and moreover we use the SAS Software procedure "PROC POWER" for the estimation of the sample size. But however we wanted it to be more accurate sample size for that we want to include the deletti tables.

» These tables […] are hopelessly behind state of the art!
» » NB, if you are interested in reference-scaling (FDA: RSABE, EMA: ABEL) you need yet other tables (covered designs: TRR|RTR|RRT and TRTR|RTRT).3 No tables exist for other designs (e.g., TRT|RTR – which is better than the lousy partial replicate), Health Canada’s ABEL, and the FDA’s RSABE for NTIDS.

Yes

» Hence, I strongly suggest to opt for software, i.e., package PowerTOST4 for R which supports all of those (plus paired and parallel designs, non-inferiority/-superiority, Fieller’s CI of ratios, dose-proportionality, …).

yes we are thinking to opt this package. But however we have a concern whether regulatory will accept it or not. Sometime ago I have faced the concern regarding the Software validation from the regulatory. By then we are doubtfull of using this package.