Bioequivalence and Bioavailability Forum

Regulatory acceptance of PowerTOST [Software]

posted by BE-proff – 2016-06-02 16:35 (2877 d 19:02 ago) – Posting: # 16382
Views: 9,666

Dear All,

Do you make references to calculations done by PowerTOST in documents submitted to regulatory authorities (i.e. study protocols, clarifications, etc)?
I mean phrases like "sample size was calculated with PowerTOST bla-bla".

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?

Thx.

---

Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

• Regulatory acceptance of PowerTOSTBE-proff 2016-06-02 14:35 
  • Regulatory acceptance of Sample size software d_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