Acceptability of software [General Statistics]
Hi Silva,
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…
Everything except spreadsheets is acceptable. I’m using Phoenix (and WinNonlin before) for ages. Quote from the Q&A-document:
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!
❝ 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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Helmut Schütz
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Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- SAS PROC GLM with group effect Silva 2014-05-19 10:57 [General Statistics]
- SAS PROC GLM with group effect ElMaestro 2014-05-19 11:51
- SAS PROC GLM with group effect Silva 2014-05-22 12:01
- SAS PROC GLM with group effect d_labes 2014-05-22 14:11
- SAS PROC GLM with group effect Silva 2014-05-22 16:54
- SAS PROC GLM with group effect d_labes 2014-05-22 14:11
- SAS PROC GLM with group effect Silva 2014-05-22 12:01
- SAS PROC GLM with group effect d_labes 2014-05-19 13:02
- SAS PROC GLM with group effect Silva 2014-05-23 12:12
- SAS PROC GLM with group effect ElMaestro 2014-05-23 12:31
- Acceptability of softwareHelmut 2014-05-23 12:47
- Acceptability of software Lucas 2014-11-14 12:21
- Acceptability of software Helmut 2014-11-14 14:11
- Acceptability of software Lucas 2014-11-14 12:21
- SAS PROC GLM with group effect ElMaestro 2014-05-19 11:51