Acceptability of software [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2014-05-23 14:47 (3597 d 05:26 ago) – Posting: # 12994
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Hi Silva,

❝ For Bioequivalence statistics (ANOVA and CI's calculation), is it Phoenix so acceptable as SAS for FDA?


It is a common misunderstanding that the FDA requires SAS for statistical evaluation of anything. Software (and code/macros within) have to be validated – that’s cumbersome. Only blackbox-validation is possible for commercial software. As the name already implies, open-source (like R) additionally offers access to the source-code…

❝ And for EMA?


Everything except spreadsheets is acceptable. I’m using Phoenix (and WinNonlin before) for ages. Quote from the Q&A-document:

3.3. Alternative computer programs
Results obtained by alternative, validated statistical programs are also acceptable except spreadsheets because outputs of spread­sheets are not suitable for secondary assessment.


For hints about validation of software see the Guidelines / Guidances.


PS: In the future please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post!

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