Bioequivalence and Bioavailability Forum

Hi Dr Anonymous!

❝ […] however I guess while we represent in CDISC it has to be in the form of YYYY-MM-DD for the .XPT.

Right. The FDA’s Technical Specifications Document (January 2019) states:

4.1.4.2 Dates in SDTM and SEND
Dates in SDTM and SEND domains should conform to the ISO 8601 format.

I was confused because you wrote:

❝ ❝ ❝ Also, when it comes to Adam datasets it specially requires SAS date format […]

Hence, no hassle since ISO 8601 in all of its flavours is the standard in R. See the format option of strptime() for the Date-Time Classes POSIXct and POSIXlt.

❝ More details to this point can be availed by […]

Sorry, I don’t have an account and don’t want to get one.

❝ Additionally, while I am fully trying to understand the datasets structure for submission, my ship hit an iceberg this morning.

❝ Under the module structure for submission for datasets as a part of the dossier, as defined by CDISC for USFDA, it requires the SAS programs for ADAM datasets to be given as note file documents.

❝ This looks clearly like CDISC recommends SAS for datasets (which is like a monopoly and it kinda brings us back to point one from where we started this thread :( ).

Really? According to the FDA’s spec’s:

3.3.1 SAS Transport Format
The XPORT is an open file format published by SAS Institute for the exchange of study data. Data can be translated to and from XPORT to other commonly used formats without the use of programs from SAS Institute or any specific vendor.
(my emphasis)

Further down Pharmacokinetics Concentrations (PC) Domain in Section 4.1.3.3 is interesting.

• Nominal timings relative to the dose in numeric or ISO 8601 format

I would prefer the former since this is what is used in PK software anyhow. Then:

When actual dates or date/time values are available for PCRFTDTC/PPRFTDTC, they can be included.

Can‽ We’re in the 21^st century, folks! Who works with nominal times – apart from binning mean data – in PK?

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