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RegisterADaM and SDTM files submission question for Generic products [Regulatives / Guidelines]
Hi,
I think the guidance doesn't specify it. However, the conc.xpt and pk.xpt are very easy to prepare; the more difficult one to prepare is SDTM which is now mandatory; so why not include both so you can forget about the issue? At least that's what I asked my CROs to do.
❝ Before CDISC became mandatory, we were submitting 2 SAS.xpt data files (PKParam.xpt and Concent.xpt with define file as PDF), now our question is do we continue to submit PKParam.xpt and Concent.xpt in addition to ADaM and SDTM files or we don’t need to submit these two files and ADaM and SDTM files are just sufficient? – This question is in regards to ANDA submissions targeted for OGD review.
I think the guidance doesn't specify it. However, the conc.xpt and pk.xpt are very easy to prepare; the more difficult one to prepare is SDTM which is now mandatory; so why not include both so you can forget about the issue? At least that's what I asked my CROs to do.
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All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- PC PP domains for CDISC submission Abc123 2017-05-29 12:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PC PP domains for CDISC submission DavidManteigas 2017-05-30 11:19
- ADaM and SDTM files submission question for Generic products Achievwin 2017-07-23 16:01
- ADaM and SDTM files submission question for Generic productsShuanghe 2017-07-24 18:53
- ADaM and SDTM files submission question for Generic products Achievwin 2017-07-23 16:01
- PC PP domains for CDISC submission DavidManteigas 2017-05-30 11:19
Ing. Helmut Schütz