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Abc123 ☆ India, 2017-05-29 14:45 (2521 d 09:32 ago) Posting: # 17425 Views: 5,809 |
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Hello! This is regarding the new CDISC requirement. I currently submit the plasma concentration data and the pharmacokinetic (Pk) data in .xpt formats for Bioequivalence studies. Is it appropriate to continue submitting these two datasets in .xpt formats, or do I have to submit it as an SDTM/ADaM domain (PC and PP)? Thank you in advance  |
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DavidManteigas ★ Portugal, 2017-05-30 13:19 (2520 d 10:58 ago) @ Abc123 Posting: # 17428 Views: 5,031 |
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Hello, The concentration and pharmacokinetic datasets you are refering are submited under module 2.7. SDTM and ADaM data are submited in module 5, so I think you should submit both datasets. Regards, David |
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Achievwin ★ US, 2017-07-23 18:01 (2466 d 06:16 ago) @ DavidManteigas Posting: # 17596 Views: 4,610 |
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Let me ask the question in a Different way: 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. Your clarification will greatly help us and thank you in advance for your guidance. AchievWin USA |
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Shuanghe ★★ Spain, 2017-07-24 20:53 (2465 d 03:24 ago) @ Achievwin Posting: # 17602 Views: 4,687 |
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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 |
Ing. Helmut Schütz