Bioequivalence and Bioavailability Forum

Software validation [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2018-10-15 13:43 (2802 d 09:36 ago) – Posting: # 19443
Views: 20,171

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 .

❝ 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. 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. PMC Free Full text.

—
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:

• Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 14:27 
  • Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 15:22
    • Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 15:58
      • Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 16:25
        • Qualitative analysis of the ANOVA resid­uals Lucas 2014-02-19 17:20
        • Qualitative analysis of the ANOVA resid­u­als Lucas 2014-02-20 19:07
          • First hints for Phoenix Helmut 2014-02-20 20:11
          • Phoenix: resid­u­als Helmut 2014-02-21 19:25
            • Phoenix: resid­u­als BRN 2014-03-04 15:15
              • Phoenix: resid­u­als Helmut 2014-03-04 16:52
            • Phoenix: resid­u­als Rosy 2018-10-15 07:03
              • Software validationHelmut 2018-10-15 11:43
                • Software validation Rosy 2018-10-18 00:38
                  • Avoid raw residuals Helmut 2018-10-18 17:14
                    • Avoid raw residuals Rosy 2018-10-18 18:05
          • Phoenix → R Helmut 2014-02-23 02:20
            • Phoenix → R Lucas 2014-02-25 19:28
  • Qualitative analysis of the ANOVA residuals ElMaestro 2014-02-19 15:32
    • Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 16:06
    • Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 16:13
      • Qualitative analysis of the ANOVA resid­u­als ElMaestro 2014-02-19 20:40