An analysis of the relationship between pharmacokinetic
and pharmacodynamic parameters and efficacy must be
included. Serum concentrations resulting from proposed
dosage regimens in humans should be used. The analysis
might include (but not be limited to): the time for which
serum or plasma levels exceed the MIC of relevant (including
anaerobic and fastidious) organisms; peak serum or plasma
level/MIC ratio; and area under the drug serum concentration
(AUC)/MIC ratio. Similar calculations for related drugs of the
same class should be provided. Data for this analysis might be
derived from experimental models of infection, from humans
given proposed dosage schedules, or from clinical studies.
Data on the postantibiotic effect and on the impact of increasing drug concentrations on bacterial killing may be helpful.