Regulatory acceptance of PowerTOST [Software]

posted by BE-proff – Russia, 2016-06-02 14:35 (1580 d 15:09 ago) – Posting: # 16382
Views: 8,369

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?:confused:

Thx.


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

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