Guidelines for submission of own data

For submission of own data, your data could either be in WinNonlin, ASCII or Excel format.

You should have arranged your dataset in the following manner:

First column should be Treatment (e.g. "Treatment A" or "Treatment B").
Second column should be subject / patient number.
Third column should be time with T=0 at the time of administration or at the beginning of an infusion.
Fourth column should be concentration provided in the same unit for all concentration data points.
Fifth column (not required) can be treatment sequence data, e.g. AB or BA, whichever sequence applies for this subject.
Sixth column (not required) can be the study period (e.g. period I or II in a standard two-way crossover study) during that the subject received the respective medication.

In addition to those data you need the dose(s) and time(s) of administration for each subject / patient, the mode of administration as well as the units for concentration and dose.

There should be no blank cells. You should repeat the subject number and treatment information for every concentration-time data point of a subject.

If there is a missing value e.g. for a concentration data point, then you should use one abbreviation (e.g. "Missing") in every concentration cell without data. "Missing" should also be written in cells for samples with concentrations below the quantification limit.

Please use "_" instead of spaces in variable names (first row should be column header)
as well as "." as decimal symbol.

A simple example of a WinNonlin raw data table can be downloaded under this link.
An example of a WinNonlin raw data table that allows also for statistical analysis of a two-way crossover study can be downloaded under this link.