Pharmacokinetic parameters that are also useful for simulation, calculation of pharmacokinetic/pharmacodynamic relationships, and comparisons with other drugs of the same class
must be provided. These parameters must include bioavailability, Cmax, AUC, volume of distribution, protein binding (and
its effect on MIC and pharmacokinetic and pharmacodynamic
parameters), metabolism (including data on microbiological
activity of metabolites), excretion (with kinetics and effects of
pH and cations in urine, if relevant), clearance, and elimination half-life. The number of subjects should be governed by
good statistical assessments.