Bioequivalence and Bioavailability Forum • CDISC datasets from R. Why not?

CDISC datasets from R. Why not? [Software]

posted by WhiteCoatWriter – India, 2019-03-21 13:13 (1538 d 00:07 ago) – Posting: # 20065
Views: 7,453

❝ Correct. The FDA nowhere mandates SAS or recommends any particular software. E.g., Certara provides the Phoenix CDISC Navigator for import/export in Phoenix/WinNonlin.

While Phoenix needs an additional package to be purchased, I feel that the same can be done by creating tables on phoenix(or importing in .csv) and exporting it to .xpt without the specific package which I assume will only help with limited datasets.

❝ If you are an experienced R-coder, consider writing a package (see here and there). The community will love you.

I might not be an expert coder/programmer, but I have been working on this for quite some time. Thank you for the references, will definitely try doing something. It really has been a challenge to get it validated using pinnacle validator. Also, when it comes to Adam datasets it specially requires SAS date format which I assume is not possible to be created on R.

Elsewhere,
While No other regulatory mandates datasets for Bio equivalence study, I still keep wondering what really sparked the USFDA in the mid of Dec 2016 to make CDISC datasets mandate for regulatory submission.

—
Thanks and Regards
Dr Anonymous
(WhiteCoatWriter)

Complete thread:

CDISC datasets or R. Acceptable ?? WhiteCoatWriter 2019-03-21 07:13 [Software]
- CDISC datasets from R. Why not? Helmut 2019-03-21 10:47
  - CDISC datasets from R. Why not?WhiteCoatWriter 2019-03-21 12:13
    - CDISC datasets from R. Why not? Helmut 2019-03-21 16:43
      - CDISC datasets from R. Why not? WhiteCoatWriter 2019-03-22 06:56
        
        Some code Helmut 2019-03-22 16:58
        
        Some code WhiteCoatWriter 2019-03-24 07:59
        
        SAS only? Helmut 2019-03-24 12:34
        
        SAS only? WhiteCoatWriter 2019-03-25 09:39
        
        Confusing… Helmut 2019-03-25 13:44
        
        Confusing… WhiteCoatWriter 2019-03-27 06:55