Note: Phoenix 8.4 only supports PK Submit 2.1 or higher.
PK Submit is a Phoenix Plugin designed to automate the complex task of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. Using PK Submit, automatically create a complete electronic regulatory submission-ready package during the normal process of setting up and executing a non-compartmental analysis (NCA).
PK Submit supports the generation of CDISC domains in either the SDTM (Study Data Tabulation Model) or the SEND (Standard for Exchange of Nonclinical Data) format.
CDISC SDTM is a unified way of transmitting information in drug studies with precise column names and a common file format. The CDISC STDM implementation in PK Submit is compliant with the standards in the SDTM Implementation Guide: Human Clinical Trials version 3.2/3.3/3.4.
CDISC SEND is an implementation of SDTM for nonclinical studies and specifies a consistent format for presenting and exchanging nonclinical data. The CDISC SEND implementation in PK Submit is compliant with the standards in the SEND Implementation Guide: Nonclinical Studies Version 3.0/3.1/3.1.1.
The CDISC ADaM implementation in PK Submit is compliant with the standards in the Analysis Data Model Implementation Guide Version 2.1.
Full documentation for PK Submit is located on the PK Submit Assistance website.
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