Bioequivalence and Bioavailability Forum • Of historic(al) interest only

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

posted by sury – India, 2019-03-20 06:04 (1857 d 03:24 ago) – Posting: # 20052
Views: 6,393

❝ […] 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.

BTW thanks for your reply. It has been a great help....

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

Deletti tables for sample size sury 2019-03-19 12:22
- Of historic(al) interest only Helmut 2019-03-19 13:27
  - Of historic(al) interest onlysury 2019-03-20 05:04
    - Software validation – again and again Helmut 2019-03-20 12:12
      - Software validation – again and again nobody 2019-03-20 16:20
        
        Fiaker und Apfelstrudel Helmut 2019-03-20 16:35
        
        Fiaker und Apfelstrudel nobody 2019-03-20 17:34
        
        Fiaker und Apfelstrudel Helmut 2019-03-20 17:54
        
        Fiaker und Apfelstrudel d_labes 2019-03-20 18:39
        Fiaker und Apfelstrudel ElMaestro 2019-03-20 22:09
      - White-box validation mittyri 2019-03-20 21:09
        
        White-box validation Helmut 2019-03-21 00:19
    - Power of Proc Power d_labes 2019-03-20 18:37