Bioequivalence and Bioavailability Forum

❝ Dear guys,

SOP system for using winNonlin and data QC? What aspects need to be considered?

This is going to be a big task if you are starting from scratch and this is what I am thinking;

You have to divide the scope of work you are doing (Modeling, NCA PK analysis or BE computations and plotting)

for each aspect you have to validate 1) data import, 2) data manipulation (e.g. NCA PK calculations) and plotting.

Take a true data from any study run each step and make sure that output you get from each step meet the pre-defined limits (two decimal points, or +/- 5%) etc.)
once you are done with individual components validation run the entire program using WinNonlin and compare against out put you got from another standard software like SAS.

Document all your efforts for future reference.

Hope this helps,

AchievWin