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.