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RegisterCDISC datasets from R. Why not? [Software]
» 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.
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)
Thanks and Regards
Dr Anonymous
(WhiteCoatWriter)
Complete thread:
- CDISC datasets or R. Acceptable ?? WhiteCoatWriter 2019-03-21 07:13 [Software]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- Confusing… Helmut 2019-03-25 13:44
- SAS only? WhiteCoatWriter 2019-03-25 09:39
- SAS only? Helmut 2019-03-24 12:34
- Some code WhiteCoatWriter 2019-03-24 07:59
- Some code Helmut 2019-03-22 16:58
- CDISC datasets from R. Why not? WhiteCoatWriter 2019-03-22 06:56
- CDISC datasets from R. Why not? Helmut 2019-03-21 16:43
- CDISC datasets from R. Why not? WhiteCoatWriter 2019-03-21 12:13
- CDISC datasets from R. Why not? Helmut 2019-03-21 10:47
Ing. Helmut Schütz