Bioequivalence and Bioavailability Forum • Paired designs not that uncommon

Paired designs not that uncommon [Power / Sample Size]

posted by ElMaestro – Denmark, 2011-12-13 18:04 (5302 d 00:29 ago) – Posting: # 7776
Views: 11,002

Dear Helmut,

❝ @All: Can we use an undocumented (!) function (of any software), even if we validate it against published datasets or other software?

From a QA perspective, "such things" (and I am just trying to speak broadly here) are often about qualification and/or validation. So, we now have another card on the table which is whether a function is documented or not.

I guess we need to find out what it implies to document, qualify and validate a function in some stats software. Once we have that in place we can discuss if a script that uses this software needs to be validated, qualified (and please let's mess as much up as possible by introducing flavours of IQ, OQ, PQ) or just documented and how.
Anyone know of a regulator who knows the difference between a function and a script?

"Aaaah, they use SAS. SAS is validated. This dossier will get my nod."

—
Pass or fail!
ElMaestro

Complete thread:

Sample size calculations: SAS vs PowerTOST/FARTSSIE Oiinkie 2011-12-06 14:30
- Sample size calculations: SAS vs PowerTOST/FARTSSIE Helmut 2011-12-06 14:49
  - Sample size calculations: SAS vs PowerTOST/FARTSSIE Oiinkie 2011-12-07 15:57
    - The power not to know vs PowerTOST/FARTSSIE/... d_labes 2011-12-12 15:38
      - Paired designs not that uncommon Helmut 2011-12-12 17:05
        
        Paired designs not that uncommonElMaestro 2011-12-13 17:04
        
        Off topic: software validation Helmut 2011-12-13 18:10
        
        Off topic: software validation ElMaestro 2011-12-13 20:30
        
        Off topic: software validation Helmut 2011-12-14 14:14
        
        Discovery of Owen's Q in SAS d_labes 2011-12-14 15:34
      - Paired designs in PowerTOST 0.9-0 Helmut 2011-12-19 20:05