PKS Object

PKS is a database system for secure storage of study data and analyses. The PKS provides a secure data management system with complete auditing capabilities. The combination of the PKS and Phoenix provides an effective means to share source data, models, scripts, and results among the members of a drug development team. The combination also supports compliance with the U.S. Food and Drug Administration’s 21 CFR Part 11 regulation.

Phoenix can work in conjunction with the PKS for secure storage and change tracking for data and analyses. This chapter covers the use of Phoenix as a PKS client: loading PKS data to Phoenix and saving data from Phoenix as PKS studies and scenarios. The PKS can also be accessed by way of a Web interface, which provides additional operations, and an XML API. The PKS functions and operations are covered in the PKS User’s Guide.

This section contains the following topics:

The PKS information structure

Dosing

Setting up a PKS connection

PKS Browser

Creating a PKS study

PKS study properties

PKS study data

Detaching PKS objects from source

PKS Save and Save As options

Configuring default save options

Loading and exporting multiple PKS objects

Global Library objects

PKS Job Viewer


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