Software validation [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2018-10-15 11:43 (777 d 22:21 ago) – Posting: # 19443
Views: 8,607

Hi Rosy,

» I do studentized residual test with R for the outliers detection, but now my regulation prohibid to use R.

Bizarre. Consider presenting the document

R: Regulatory Compliance and Validation Issues
A Guidance Document for the Use of R in Regulated Clinical
Trial Environments

and to ask the agency why it believes (!) that commercial software (SAS, Phoenix, …) is “better” than open source. Any software has to be validated* – which is easy for base [image].

» Can i do with phoenix 7 or another statistical software like ncss.

In Phoenix you get only standardized residuals (aka internally studentized residuals). For the setup see above. In SAS both internally and externally studentized residuals are possible. Haven’t used NCSS for 15+ years – no idea.


* Examples where a commercial software screwed up:
  1. Schütz H, Labes D, Fuglsang A. Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies. AAPS J. 2014;16(6):1292–7. doi:10.1208/s12248-014-9661-0. [image] PMC Free Full text.
  2. Fuglsang A, Schütz H, Labes D. Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design. AAPS J. 2015;17(2):400–4. doi:10.1208/s12248-014-9704-6. PMID 25488055. [image] PMC Free Full text.

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Helmut Schütz
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