The terms ‘bioanalytical analysis’ and ‘pharmacokinetic analysis’ are commonly used interchangeably, despite slight differences in meaning.
Bioanalytical data refers to measured concentrations of a drug in a specified matrix (e.g., plasma or blood). Outputs of a bioanalytical analysis typically pertain to summaries of the concentration data. This includes data listings of the concentration data for each subject presented as descriptive statistics (such as mean and standard deviation) or figures of the drug concentration over time showing individual subject profiles as well as a mean concentration profile.
Pharmacokinetic data refers to metrics that describe how drugs are absorbed, distributed, metabolized and eliminated by the body. Outputs for a pharmacokinetic analysis typically pertain to summaries of obtained pharmacokinetic metrics such as the maximum concentration achieved after a drug has been administered or the area under the concentration time curve. These data are typically output in a table listing for each individual and as descriptive statistics for the study population (potentially stratified by a specific patient characteristic as warranted).