ADaM and SDTM files submission question for Generic products [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2017-07-24 20:53 (2762 d 08:53 ago) – Posting: # 17602
Views: 5,134

Hi,

❝ 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.

All the best,
Shuanghe

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