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SDTM - Wikipedia

SDTM Study Data Tabulation Model defines a standard structure for human clinical trial study data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration FDA .

Link: https://en.wikipedia.org/wiki/SDTM

Actived: Sunday Jul 14, 2019 (2 days ago)

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Submission of Pharmacokinetics PK Data in a CDISC

Submission of Pharmacokinetics PK Data in a CDISC Compliant Format Yu Zhu PPD LLC. Shanghai ABSTRACT The legacy Pharmacokinetic PK data are usually produced from different sources with different data format sample collection on CRF concentration results from Lab findings and parameters calculated by pharmacokineticist. This brings a lot challenge when preparing SDTM and ADaM datasets

Link: https://lexjansen.com/pharmasug-cn/2014/CD/PharmaSUG-China-2014-CD10.pdf

Actived: Saturday Jul 13, 2019 (3 days ago)

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Fast track to Domain SDTM.PC and SDTM.PP Use Graphic

Fast track to Domain SDTM.PC and SDTM.PP Use Graphic overview of variables to speed up learnings curve. Lina Ulkj r J rgensen Novo Nordisk A S Bagsv rd Denmark ABSTRACT Pharmacokinetics concentration PC and Pharmacokinetics Parameters PP Domain Models are described in CDISC Implementation Guide. To work with these domains gives some challenges. This poster shows all variables on a

Link: https://www.lexjansen.com/phuse/2016/pp/PP20.pdf

Actived: Friday Jul 12, 2019 (4 days ago)

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SDTM CDISC

SDTM v1.5 includes content that is more broadly applicable to the SDTM family of implementation guides such as Text corrections and clarifications. It introduces the concept of domain specific variables.

Link: https://www.cdisc.org/standards/foundational/sdtm

Actived: Sunday Jul 14, 2019 (2 days ago)

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Understanding PK CDISC Standards Requirements

The relevant pharmacokinetic PK domains for SEND and SDTM are the PC domain which stands for pharmacokinetic concentrations the PP domain which stands for pharmacokinetic parameters and the RELREC domain which stands for related records. The relevant ADaM PK domains are the ADPC and the ADPP which can be used for pharmacokinetic analyses.

Link: https://www.nuventra.com/resources/blog/cdisc-part-2/

Actived: Sunday Jul 14, 2019 (2 days ago)

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Study Data Tabulation Model Implementation Guide

CDISC SDTM Implementation Guide Version 3.1.2

Link: http://meta-x.com/cdisc/doc/SDTM%20Implementation%20Guide%20V3.1.2.pdf

Actived: Friday Jul 12, 2019 (4 days ago)

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SEND Implementation Wiki - SEND Fundamentals - PhUSE Wiki

A field used in a domain Corresponds to an SDTM column Usually prefixed with the domain code A variable is a field or column used in part to describe a record for a domain. For instance the Body Weights domain s BWDTC variable is used to describe the datetime DTC at which a body weight was collected. Typically variables are prefixed with the domain 2-letter code then followed by the

Link: https://www.phusewiki.org/wiki/index.php?title=SEND_Implementation_Wiki_-_SEND_Fundamentals

Actived: Wednesday Jul 10, 2019 (6 days ago)

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in CDISC Standards

PK Data in SDTM Specific pharmacokinetics domains based on General Observation class were introduced in SDTMIG v. 3.1.2 PC Pharmacokinetics Concentration for time-concentration profiles PP Pharmacokinetics Parameters for PK results Dosing information like treatment and dose amount are in EX domain Some subject data like AGE SEX RACE are in DM domain Additional

Link: https://www.cdisc.org/system/files/all/Education/PK_Webinar_Dec2014_CDISC_Published.pdf

Actived: Saturday Jul 13, 2019 (3 days ago)

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Performing CDISC Compliant Pharmacokinetic Analyses

The PP domain has a structure of one record per PK parameter per concentration-time profile and although the data presented are not considered to be observed data the submission of PK Parameters fits well into the SDTM general observation class model. Indeed most FDA reviewers prefer PK data to be submitted in the form of an SDTM dataset.

Link: https://www.quanticate.com/blog/bid/100300/Performing-CDISC-Compliant-Pharmacokinetic-Analyses

Actived: Saturday Jul 13, 2019 (3 days ago)

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DS10 Considerations in the Submission of Pharmacokinetics

1 PharmaSUG 2012 - Paper DS10 Considerations in the Submission of Pharmacokinetics PK Data in an SDTM-Compliant Format Fred Wood Octagon Research Solutions Wayne PA

Link: https://www.pharmasug.org/proceedings/2012/DS/PharmaSUG-2012-DS10.pdf

Actived: Monday Jul 8, 2019 (8 days ago)

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