English to Russian Medical Medical: Pharmaceuticals PK analysis

Every effort will be made to include all concentration data in an analysis. If that were not to
be possible, a case to case decision iwill be taken as to whether the value should only be
excluded from half-life estimation or the complete analysis.
∗ If a concentration is only excluded from half-life determination, it will be used for all other
calculations (e.g. descriptive statistics) and for graphical presentation.
∗ If a concentration value is excluded from all calculations, it will not be presented
graphically or used for the calculation of descriptive statistics and parameter determination.
However the excluded concentration itself will be listed and associated
with an appropriate flag.
Descriptive statistics of parameters are calculated only when at least 2/3 of the individual
parameter estimates of a certain parameter are available. If the actual sampling time will not
be recorded or will be missing for a certain time point, the planned time will generally be
used for this time point instead. Pharmacokinetic parameters which cannot be determined will
be identified by "not calculated" (NC).