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[Free White Paper]

The Benefits Of A Pharmacokinetics

Handover Document in PK Studies

The transfer of Pharmacokinetic (PK) data between statistics and programming departments can lead to confusion over the presentation, summary and analyses of PK data. Delivering a PK Handover Document alongside the output file(s) of PK Parameters from a non-compartmental analysis (NCA) can eliminate these issues.

This document can be helpful to create a more efficient process from PK analysis to the release of the final Tables, Listings and Figures (TLFs), by documenting: 

  • Data issues and associated decisions in the analysis of the PK data
  • Subsequent action that needs to be taken by Stats & Programming team
  • Version history and the flow of data between departments

This white paper illustrates how a PK Handover Document should be customized, detailing, ideally, what kind of information should contain.

PK Handover Document

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