Correlation of elimination fraction area under the curve with total body clearance.

This study attempted to determine the area under the curve ([Formula: see text]), which corresponds to the sum of all elimination processes correlated with the total clearance value. The study attempted to determine the [Formula: see text] based on the coordinates known from classic non-compartmental pharmacokinetics for a single administration of the drug. 318 pharmacokinetics profiles were used for the analysis, obtained from 220 healthy subjects over ten studies.

Evaluation of sampling spacing in pharmacokinetic studies using six sigma method.

Key elements of pharmacokinetics (PK) studies include both, the number of sampling points (NSP) as well as the spacing between the sampling points (SSP). Optimization of the SSP is discussed in guidelines of all key regulatory agencies (RA). Those however, provide only very general rules on how to properly distribute the NSPs in proposed PK studies.