Bioequivalence and Bioavailability Forum

Regulatory acceptance of Sample size software [Software]

posted by d_labes  – Berlin, Germany, 2016-06-02 17:05 (3321 d 23:52 ago) – Posting: # 16384
Views: 9,825

Dear BE-proff,

❝ AFAIK, authorities want to see validated software while R-based scripts seem not to be validated...

❝ How to prove officials that PowerTOST is reliable soft?

I'm not a friend of software validation, whatever that is.

Ask the same question to statements like:
"I have calculated the sample size with SAS, PASS, nQuery, Brain-Pencil-Paper ... (or whatever soft-/wetware you prefer ). Is that SAS, PASS, nQuery, Brain-Pencil-Paper ... validated and reliable?"

See also this thread.

Then act. Others, more trained in this ugly field of software validation may give you more hints what to do in detail. In short:

• Write a validation plan
• Do what you have written in the validation plan
• Write a validation report

BTW: PowerTOST is not an R-based script. It is a package providing you the possibility (via functions) to estimate power / sample size with your R-based script.

Complete thread:

• Regulatory acceptance of PowerTOST BE-proff 2016-06-02 14:35 [Software] 
  • Regulatory acceptance of Sample size softwared_labes 2016-06-02 15:05
  • PowerTOST/Power2Stage: no issues so far Helmut 2016-06-02 15:39
  • Regulatory acceptance of PowerTOST DavidManteigas 2016-06-03 11:05
    • Regulatory acceptance of PowerTOST BE-proff 2016-06-03 22:30
      • Regulatory acceptance of PowerTOST Helmut 2016-06-04 15:51
        • Regulatory acceptance of PowerTOST BE-proff 2016-06-07 15:15
  • Regulatory acceptance of PowerTOST ElMaestro 2016-06-04 16:12
    • Regulatory acceptance of PowerTOST BE-proff 2016-06-07 15:17
      • Regulatory acceptance of PowerTOST mittyri 2016-06-08 07:51
        • Regulatory acceptance of PowerTOST Astea 2016-06-14 17:41